TerminatedPhase 2Results posted

Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE, IN ADULTS WITH TYPE 2 DIABETES MELLITUS (T2DM) INADEQUATELY CONTROLLED ON METFORMIN, AND SEPARATELY PF-07081532 COMPARED TO MATCHING PLACEBO IN ADULTS WITH OBESITY BUT WITHOUT T2DM

Lead sponsor

Pfizer

Assets

GLP-1 / incretin class catch-all / Lotiglipron / Semaglutide

Listed sites

Recruiting sites

Actual enrollment

902

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥23•HbA1c 7-10%

Primary endpoints

•HbA1c, % change•Body weight, % change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05579977

Org study IDC3991004

Secondary ID2022-002834-15

Timeline

Milestones

Study first posted2022-10-14actual

Study start2022-10-27actual

Primary completion2023-07-14actual

Study completion2023-09-22actual

Last update posted2024-08-01actual

Results first posted2024-08-01actual

Assets

Investigational agents

GLP-1 / incretin class catch-all Lotiglipron Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

T2DM

•T2DM inadequately controlled with metformin

•BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan)

•HbA1C of 7% to 10% (53-86 mmol/mol)

•FPG ≤270 mg/dL (15 mmol/L)

Obesity

•BMI ≥30.0 kg/m2

•HbA1C ≤6.4% (47 mmol/mol)

•FPG ≤126 mg/dL (7 mmol/L)

Exclusion criteria

•Any of the following: Active/current, symptomatic gallbladder disease; History of pancreatitis in the prior 2-months;History of Type 1 Diabetes Mellitus, or secondary forms of diabetes; Any condition affecting drug absorption; Medical history of active liver disease (other than non-alcoholic hepatic steatosis)

•Use of pharmacological agents with approved indication for weight loss

•T2DM:Use of any agent (other than metformin)for the explicit purpose of glycemic control;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathy requiring acute treatment;

•Obesity: Previous or planned weight reduction surgery; Major depressive disorder or other severe psychiatric disorders; Any lifetime history of a suicide attempt; PHQ-9 score ≥15; Response of "yes" to Question 4 or 5, or on any suicidal behavioral question on the C-SSRS

•Clinically significant cardiovascular conditions

•Uncontrolled blood pressure

•Personal or within first-degree relative family history of MTC or MEN2

•Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study

•Any of the following central lab results: Fasting C-peptide <0.8 ng/mL; ALT or AST ≥2.5x ULN; Direct bilirubin >ULN or T Bili >1.5x ULN except when participants have a history of Gilbert syndrome ; TSH >1.5x ULN or <LLN; Serum calcitonin >ULN; Serum amylase or serum lipase >ULN; eGFR <45 ml/min/1.73 ; Active Hepatitis B, or Hepatitis C; A positive urine drug test for illicit drugs

Endpoints (70)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

18 endpoints

Primary/registry result

Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), week 32

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), week 32

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Percentage of Participants Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

threshold achievement, improvement

Secondary/registry result

Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

Waist circumference, change

change from baseline, improvement

Secondary/registry result

Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

change from baseline, improvement

Other/protocol endpoint

Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 20: Cohort 2 (Obesity)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 20

Body weight, % change

percent change from baseline, improvement

Other/protocol endpoint

Percent Change From Baseline in Body Weight at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

Body weight, % change

percent change from baseline, improvement

Other/protocol endpoint

Absolute Change From Baseline in Waist Circumference at Week 12 and 24: Cohort 2 (Obesity)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], Week 12, 24

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint

Absolute Change From Baseline in Waist-to-hip Ratio at Week 12 and Week 24: Cohort 2 (Obesity)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], week 12, 24

change from baseline, improvement

Other_pre_specified/registry result

Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 20: Cohort 2 (Obesity)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 20

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Least-squares mean · Percent change	95% CI
Placebo (Obesity)	-1.84	-
PF-07081532 80mg (Obesity)	-4.28	-
PF-07081532 140mg (Obesity)	-6.21	-
PF-07081532 200mg (Obesity,5 Steps)	-7.47	-
PF-07081532 200mg (Obesity,4 Steps)	-6.88	-
PF-07081532 260mg (Obesity)	-7.26	-

Ls mean difference-2.4490% CI-3.88 - -1.00p0.0055Mixed Models Analysis

Ls mean difference-4.3790% CI-5.84 - -2.89p<.0001Mixed Models Analysis

Ls mean difference-5.6390% CI-7.07 - -4.18p<.0001Mixed Models Analysis

Ls mean difference-5.0490% CI-6.50 - -3.58p<.0001Mixed Models Analysis

Ls mean difference-5.4290% CI-6.91 - -3.93p<.0001Mixed Models Analysis

Other_pre_specified/registry result

Percent Change From Baseline in Body Weight at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Mean · Percent change	95% CI
Placebo (T2DM)	93.164	-
PF-07081532 20mg (T2DM)	86.251	-
PF-07081532 40mg (T2DM)	91.556	-
PF-07081532 80mg (T2DM)	92.979	-
PF-07081532 160mg (T2DM)	85.564	-
PF-07081532 260mg (T2DM)	87.658	-
Rybelsus 14mg (T2DM)	91.799	-

Other_pre_specified/registry result

Absolute Change From Baseline in Waist Circumference at Week 12 and 24: Cohort 2 (Obesity)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], Week 12, 24

Waist circumference, change

change from baseline, improvement

Posted result

Group	Mean · Centimeter	95% CI
Placebo (Obesity)Week 12	-2.702	-
Week 24	-4.233	-
PF-07081532 80mg (Obesity)Week 12	-2.574	-
Week 24	-5.147	-
PF-07081532 140mg (Obesity)Week 12	-3.017	-
Week 24	-6.314	-
PF-07081532 200mg (Obesity,5 Steps)Week 12	-3.559	-
Week 24	-2.722	-
PF-07081532 200mg (Obesity,4 Steps)Week 12	-2.191	-
Week 24	-10.297	-
PF-07081532 260mg (Obesity)Week 12	-1.079	-
Week 24	-6.450	-

Other_pre_specified/registry result

Absolute Change From Baseline in Waist-to-hip Ratio at Week 12 and Week 24: Cohort 2 (Obesity)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], week 12, 24

change from baseline, improvement

Posted result

Group	Mean · Ratio	95% CI
Placebo (Obesity)Week 12	-0.013	-
Week 24	-0.023	-
PF-07081532 80mg (Obesity)Week 12	-0.002	-
Week 24	-0.017	-
PF-07081532 140mg (Obesity)Week 12	-0.006	-
Week 24	-0.032	-
PF-07081532 200mg (Obesity,5 Steps)Week 12	-0.010	-
Week 24	0.018	-
PF-07081532 200mg (Obesity,4 Steps)Week 12	-0.002	-
Week 24	-0.009	-
PF-07081532 260mg (Obesity)Week 12	0.015	-
Week 24	-0.037	-

Glycemic / diabetes

22 endpoints

Primary/registry result

Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/registry result

Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity)

Time frame:Baseline (result closest prior to dosing on Day 1), Week 32

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other/protocol endpoint

Placebo-adjusted, Change From Baseline in Percentage of HbA1C in the Rybelsus Arm Versus Placebo Arm at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 16: Cohort 2 (Obesity)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 16: Cohort 2 (Obesity)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other_pre_specified/registry result

Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · % HbA1c	95% CI
Placebo (T2DM)	-0.07	-
PF-07081532 20mg (T2DM)	-1.03	-
PF-07081532 40mg (T2DM)	-1.37	-
PF-07081532 80mg (T2DM)	-1.44	-
PF-07081532 160mg (T2DM)	-1.34	-
PF-07081532 260mg (T2DM)	-1.36	-
Rybelsus 14mg (T2DM)	-0.94	-

Ls mean difference-0.9590% CI-1.20 - -0.70p<.0001Mixed Models Analysis

Ls mean difference-1.3090% CI-1.55 - -1.04p<.0001Mixed Models Analysis

Ls mean difference-1.3790% CI-1.62 - -1.11p<.0001Mixed Models Analysis

Ls mean difference-1.2690% CI-1.52 - -1.01p<.0001Mixed Models Analysis

Ls mean difference-1.2990% CI-1.55 - -1.03p<.0001Mixed Models Analysis

Ls mean difference-0.8690% CI-1.12 - -0.61p<.0001Mixed Models Analysis

Other_pre_specified/registry result

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Mean · Milligrams per deciliter	95% CI
Placebo (T2DM)	160.70	-
PF-07081532 20mg (T2DM)	135.59	-
PF-07081532 40mg (T2DM)	127.00	-
PF-07081532 80mg (T2DM)	132.19	-
PF-07081532 160mg (T2DM)	127.65	-
PF-07081532 260mg (T2DM)	125.07	-
Rybelsus 14mg (T2DM)	130.06	-

Other_pre_specified/registry result

Placebo-adjusted, Change From Baseline in Percentage of HbA1C in the Rybelsus Arm Versus Placebo Arm at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percentage of HbA1C	95% CI
Rybelsus 14mg (T2DM)	-0.94	-
Placebo (T2DM)	-0.07	-

Ls mean difference-0.8690% CI-1.12 - -0.61p<.0001Mixed Models Analysis

Other_pre_specified/registry result

Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 16: Cohort 2 (Obesity)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Mean · Milliunits per liter	95% CI
Placebo (Obesity)	0.630	-
PF-07081532 80mg (Obesity)	0.185	-
PF-07081532 140mg (Obesity)	-0.121	-
PF-07081532 200mg (Obesity,5 Steps)	0.984	-
PF-07081532 200mg (Obesity,4 Steps)	-1.172	-
PF-07081532 260mg (Obesity)	-0.210	-

Other_pre_specified/registry result

Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 16: Cohort 2 (Obesity)

Time frame:Baseline [(Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1)], at Week 16

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Mean · Percentage sensitivity	95% CI
Placebo (Obesity)	-2.419	-
PF-07081532 80mg (Obesity)	1.594	-
PF-07081532 140mg (Obesity)	7.807	-
PF-07081532 200mg (Obesity,5 Steps)	-7.085	-
PF-07081532 200mg (Obesity,4 Steps)	3.497	-
PF-07081532 260mg (Obesity)	-2.045	-

Safety / tolerability / PK

30 endpoints

Secondary/registry result

Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Participants	95% CI
Placebo (T2DM)	35	-
PF-07081532 20mg (T2DM)	37	-
PF-07081532 40mg (T2DM)	50	-
PF-07081532 80mg (T2DM)	44	-
PF-07081532 160mg (T2DM)	45	-
PF-07081532 260mg (T2DM)	56	-
Rybelsus 14mg (T2DM)	36	-

Secondary/registry result

Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Participants	95% CI
Placebo (Obesity)	44	-
PF-07081532 80mg (Obesity)	54	-
PF-07081532 140mg (Obesity)	50	-
PF-07081532 200mg (Obesity,5 Steps)	56	-
PF-07081532 200mg (Obesity,4 Steps)	60	-
PF-07081532 260mg (Obesity)	53	-

Secondary/registry result

Number of Participants With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Serious AEs (any)

event count, event

Posted result

Group	Participants	95% CI
Placebo (T2DM)	1	-
PF-07081532 20mg (T2DM)	0	-
PF-07081532 40mg (T2DM)	3	-
PF-07081532 80mg (T2DM)	3	-
PF-07081532 160mg (T2DM)	1	-
PF-07081532 260mg (T2DM)	2	-
Rybelsus 14mg (T2DM)	1	-

Secondary/registry result

Number of Participants With Serious Adverse Events (SAEs): Cohort 2 (Obesity)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Serious AEs (any)

event count, event

Posted result

Group	Participants	95% CI
Placebo (Obesity)	1	-
PF-07081532 80mg (Obesity)	2	-
PF-07081532 140mg (Obesity)	2	-
PF-07081532 200mg (Obesity,5 Steps)	1	-
PF-07081532 200mg (Obesity,4 Steps)	2	-
PF-07081532 260mg (Obesity)	2	-

Secondary/registry result

Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Discontinuation due to AE

event count, event

Posted result

Group	Participants	95% CI
Placebo (T2DM)Discontinuations from study due to TEAEs	1	-
Permanent discontinuations from any study intervention due to TEAEs	0	-
PF-07081532 20mg (T2DM)Discontinuations from study due to TEAEs	0	-
Permanent discontinuations from any study intervention due to TEAEs	3	-
PF-07081532 40mg (T2DM)Discontinuations from study due to TEAEs	0	-
Permanent discontinuations from any study intervention due to TEAEs	11	-
PF-07081532 80mg (T2DM)Discontinuations from study due to TEAEs	0	-
Permanent discontinuations from any study intervention due to TEAEs	10	-
PF-07081532 160mg (T2DM)Discontinuations from study due to TEAEs	0	-
Permanent discontinuations from any study intervention due to TEAEs	5	-
PF-07081532 260mg (T2DM)Discontinuations from study due to TEAEs	0	-
Permanent discontinuations from any study intervention due to TEAEs	17	-
Rybelsus 14mg (T2DM)Discontinuations from study due to TEAEs	0	-
Permanent discontinuations from any study intervention due to TEAEs	5	-

Secondary/registry result

Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Discontinuation due to AE

event count, event

Posted result

Group	Participants	95% CI
Placebo (Obesity)Discontinuations from study due to TEAEs	0	-
Permanent discontinuations from any study intervention due to TEAEs	5	-
PF-07081532 80mg (Obesity)Discontinuations from study due to TEAEs	0	-
Permanent discontinuations from any study intervention due to TEAEs	12	-
PF-07081532 140mg (Obesity)Discontinuations from study due to TEAEs	1	-
Permanent discontinuations from any study intervention due to TEAEs	19	-
PF-07081532 200mg (Obesity,5 Steps)Discontinuations from study due to TEAEs	0	-
Permanent discontinuations from any study intervention due to TEAEs	15	-
PF-07081532 200mg (Obesity,4 Steps)Discontinuations from study due to TEAEs	0	-
Permanent discontinuations from any study intervention due to TEAEs	24	-
PF-07081532 260mg (Obesity)Discontinuations from study due to TEAEs	1	-
Permanent discontinuations from any study intervention due to TEAEs	22	-

Secondary/registry result

Number of Participants With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Up to week 28

Documented hypoglycemia

event count, event

Posted result

Group	Participants	95% CI
Placebo (T2DMSevere Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	1	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 20mg (T2DM)Severe Hypoglycemia	1	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	1	-
PF-07081532 40 mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	2	-
Asymptomatic Hypoglycemia	1	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 60mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	1	-
Asymptomatic Hypoglycemia	1	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 80 mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	1	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 120 mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	1	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 140mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	1	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 160mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	1	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 200mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 260 mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
Rybelsus 3mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	2	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	1	-
Rybelsus 7mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	2	-
Asymptomatic Hypoglycemia	1	-
Probable Symptomatic Hypoglycemia	0	-
Rybelsus 14mg (T2DM)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	1	-
Asymptomatic Hypoglycemia	2	-
Probable Symptomatic Hypoglycemia	0	-

Secondary/registry result

Number of Participants With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity)

Time frame:Up to week 28

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Participants	95% CI
Placebo (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 20mg (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 40 mg (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 60 mg (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 80mg (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 100 mg (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 120 mg (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 140mg (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 160 mg (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-
PF-07081532 200 mg (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	1	-
PF-07081532 260 mg (Obesity)Severe Hypoglycemia	0	-
Documented Symptomatic Hypoglycemia	0	-
Asymptomatic Hypoglycemia	0	-
Probable Symptomatic Hypoglycemia	0	-

Secondary/registry result

Number of Participants With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Up to week 28

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Posted result

Group	Participants	95% CI
Placebo (T2DM)Systolic Blood Pressure (mmHg) Value <90 mmHg	0	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	0	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	0	-
PF-07081532 20mg (T2DM)Systolic Blood Pressure (mmHg) Value <90 mmHg	0	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	4	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	1	-
PF-07081532 40mg (T2DM)Systolic Blood Pressure (mmHg) Value <90 mmHg	0	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	2	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	1	-
PF-07081532 80mg (T2DM)Systolic Blood Pressure (mmHg) Value <90 mmHg	1	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	2	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	0	-
PF-07081532 160mg (T2DM)Systolic Blood Pressure (mmHg) Value <90 mmHg	1	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	2	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	0	-
PF-07081532 260mg (T2DM)Systolic Blood Pressure (mmHg) Value <90 mmHg	0	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	1	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	1	-
Rybelsus 14 mg (T2DM)Systolic Blood Pressure (mmHg) Value <90 mmHg	0	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	2	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	0	-

Secondary/registry result

Number of Participants With Vital Sign Abnormalities: Cohort 2 (Obesity)

Time frame:Up to week 28

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Posted result

Group	Participants	95% CI
Placebo (Obesity)Systolic Blood Pressure (mmHg) Value <90 mmHg	0	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	4	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	0	-
PF-07081532 80mg (Obesity)Systolic Blood Pressure (mmHg) Value <90 mmHg	3	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	4	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	0	-
PF-07081532 140mg (Obesity)Systolic Blood Pressure (mmHg) Value <90 mmHg	0	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	4	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	0	-
PF-07081532 200mg (Obesity,5 Steps)Systolic Blood Pressure (mmHg) Value <90 mmHg	2	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	0	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	0	-
PF-07081532 200mg (Obesity,4 Steps)Systolic Blood Pressure (mmHg) Value <90 mmHg	0	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	2	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	0	-
PF-07081532 260mg (Obesity)Systolic Blood Pressure (mmHg) Value <90 mmHg	1	-
Systolic Blood Pressure (mmHg) Value >200 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value <40 mmHg	0	-
Diastolic Blood Pressure (mmHg) Value >100 mmHg	3	-
Pulse Rate (bpm) Value <40 bpm	0	-
Pulse Rate (bpm) Value >110 bpm	0	-

Secondary/registry result

Number of Participants With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Up to week 28

threshold achievement, event

componentsplatelets low, leukocytes low or high, lymphocytes low or high, neutrophils low or high, basophils high, eosinophils high, monocytes high, prothrombin time high, inr high, bilirubin high, indirect bilirubin high, ast high, alt high, gamma gt high, urea nitrogen high, creatinine high, hdl cholesterol low, ldl cholesterol high, triglycerides high

Posted result

Group	Participants	95% CI
Placebo (T2DM)	67	-
PF-07081532 20mg (T2DM)	64	-
PF-07081532 40mg (T2DM)	57	-
PF-07081532 80mg (T2DM)	57	-
PF-07081532 160mg (T2DM)	61	-
PF-07081532 260mg (T2DM)	59	-
Rybelsus 14mg (T2DM)	64	-

Secondary/registry result

Number of Participants With Clinical Laboratory Abnormalities: Cohort 2 (Obesity)

Time frame:Up to week 28

threshold achievement, event

componentshematology abnormalities, coagulation abnormalities, clinical chemistry abnormalities, lipid abnormalities, electrolyte abnormalities, renal labs abnormalities, liver labs abnormalities

Posted result

Group	Participants	95% CI
Placebo (Obesity)	36	-
PF-07081532 80mg (Obesity)	31	-
PF-07081532 140mg (Obesity)	40	-
PF-07081532 200mg (Obesity,5 Steps)	40	-
PF-07081532 200mg (Obesity,4 Steps)	48	-
PF-07081532 260mg (Obesity)	36	-

Secondary/registry result

Number of Participants With ECG Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Up to week 28

threshold achievement, event

Posted result

Group	Participants	95% CI
Placebo (T2DM)PR Interval, (MSEC) value >=300	1	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	1	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	5	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	3	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
PF-07081532 20mg (T2DM)PR Interval, (MSEC) value >=300	0	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	0	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	7	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	7	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
PF-07081532 40mg (T2DM)PR Interval, (MSEC) value >=300	0	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	0	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	3	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	5	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
PF-07081532 80mg (T2DM)PR Interval, (MSEC) value >=300	1	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	1	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	5	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	4	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
PF-07081532 160mg (T2DM)PR Interval, (MSEC) value >=300	0	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	0	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	5	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	3	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
PF-07081532 260mg (T2DM)PR Interval, (MSEC) value >=300	0	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	0	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	2	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	10	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
Rybelsus 14mg (T2DM)PR Interval, (MSEC) value >=300	0	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	3	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	5	-
QTCF interval, single beat (MSEC) 480 < Value <=500	1	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	8	-
QTCF interval, single beat (MSEC) Chg > 60	0	-

Secondary/registry result

Number of Participants With ECG Abnormalities: Cohort 2 (Obesity)

Time frame:Up to week 28

threshold achievement, event

Posted result

Group	Participants	95% CI
Placebo (Obesity)PR Interval, (MSEC) value >=300	0	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	1	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	9	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	3	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
PF-07081532 80mg (Obesity)PR Interval, (MSEC) value >=300	0	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	0	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	3	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	8	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
PF-07081532 140mg (Obesity)PR Interval, (MSEC) value >=300	0	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	0	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	4	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	4	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
PF-07081532 200mg (Obesity,5 Steps)PR Interval, (MSEC) value >=300	0	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	0	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	1	-
QTCF interval, single beat (MSEC) 450 < Value <=480	2	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	4	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
PF-07081532 200mg (Obesity,4 Steps)PR Interval, (MSEC) value >=300	1	-
PR Interval, (MSEC) %Chg >= 25/50%	1	-
QRS duration, (MSEC) value >=140	0	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	4	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	4	-
QTCF interval, single beat (MSEC) Chg > 60	0	-
PF-07081532 260mg (Obesity)PR Interval, (MSEC) value >=300	0	-
PR Interval, (MSEC) %Chg >= 25/50%	0	-
QRS duration, (MSEC) value >=140	0	-
QRS duration, (MSEC) %Chg >=50%	0	-
QT interval, single beat (MSEC) value > 500	0	-
QTCF interval, single beat (MSEC) 450 < Value <=480	7	-
QTCF interval, single beat (MSEC) 480 < Value <=500	0	-
QTCF interval, single beat (MSEC) Value > 500	0	-
QTCF interval, single beat (MSEC) 30 <= Chg <= 60	3	-
QTCF interval, single beat (MSEC) Chg > 60	0	-

Secondary/registry result

Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Category: Cohort 2 (Obesity) Only

Time frame:Baseline (result closest prior to dosing on Day 1), anytime post-baseline (Up to Week 28)

threshold achievement, event

Posted result

Group	Participants	95% CI
Placebo (Obesity)Baseline: <1> Completed suicide	0	-
Baseline: <2> Suicide attempt	0	-
Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Baseline: <4> Suicidal ideation	0	-
Baseline: <7> Self-injurious behavior, no suicidal intent	0	-
Post-Baseline: <1> Completed suicide	0	-
Post-Baseline: <2> Suicide attempt	0	-
Post-Baseline: <3> Preparatory acts towards imminent suicidal behavior	1	-
Post-Baseline: <4> Suicidal ideation	0	-
Post-Baseline: <7> Self-injurious behavior, no suicidal intent	1	-
PF-07081532 80mg (Obesity)Baseline: <1> Completed suicide	0	-
Baseline: <2> Suicide attempt	0	-
Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Baseline: <4> Suicidal ideation	0	-
Baseline: <7> Self-injurious behavior, no suicidal intent	0	-
Post-Baseline: <1> Completed suicide	0	-
Post-Baseline: <2> Suicide attempt	0	-
Post-Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Post-Baseline: <4> Suicidal ideation	0	-
Post-Baseline: <7> Self-injurious behavior, no suicidal intent	0	-
PF-07081532 140mg (Obesity)Baseline: <1> Completed suicide	0	-
Baseline: <2> Suicide attempt	0	-
Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Baseline: <4> Suicidal ideation	0	-
Baseline: <7> Self-injurious behavior, no suicidal intent	0	-
Post-Baseline: <1> Completed suicide	0	-
Post-Baseline: <2> Suicide attempt	0	-
Post-Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Post-Baseline: <4> Suicidal ideation	0	-
Post-Baseline: <7> Self-injurious behavior, no suicidal intent	0	-
PF-07081532 200mg (Obesity,5 Steps)Baseline: <1> Completed suicide	0	-
Baseline: <2> Suicide attempt	0	-
Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Baseline: <4> Suicidal ideation	0	-
Baseline: <7> Self-injurious behavior, no suicidal intent	0	-
Post-Baseline: <1> Completed suicide	0	-
Post-Baseline: <2> Suicide attempt	0	-
Post-Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Post-Baseline: <4> Suicidal ideation	0	-
Post-Baseline: <7> Self-injurious behavior, no suicidal intent	0	-
PF-07081532 200mg (Obesity,4 Steps)Baseline: <1> Completed suicide	0	-
Baseline: <2> Suicide attempt	0	-
Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Baseline: <4> Suicidal ideation	0	-
Baseline: <7> Self-injurious behavior, no suicidal intent	0	-
Post-Baseline: <1> Completed suicide	0	-
Post-Baseline: <2> Suicide attempt	0	-
Post-Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Post-Baseline: <4> Suicidal ideation	0	-
Post-Baseline: <7> Self-injurious behavior, no suicidal intent	0	-
PF-07081532 260mg (Obesity)Baseline: <1> Completed suicide	0	-
Baseline: <2> Suicide attempt	0	-
Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Baseline: <4> Suicidal ideation	1	-
Baseline: <7> Self-injurious behavior, no suicidal intent	0	-
Post-Baseline: <1> Completed suicide	0	-
Post-Baseline: <2> Suicide attempt	0	-
Post-Baseline: <3> Preparatory acts towards imminent suicidal behavior	0	-
Post-Baseline: <4> Suicidal ideation	1	-
Post-Baseline: <7> Self-injurious behavior, no suicidal intent	0	-

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Serious Adverse Events (SAEs): Cohort 2 (Obesity)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Number of Participants Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity)

Time frame:From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Number of Participants With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Up to week 28

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity)

Time frame:Up to week 28

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Up to week 28

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Secondary/protocol endpoint

Number of Participants With Vital Sign Abnormalities: Cohort 2 (Obesity)

Time frame:Up to week 28

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Secondary/protocol endpoint

Number of Participants With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Up to week 28

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Clinical Laboratory Abnormalities: Cohort 2 (Obesity)

Time frame:Up to week 28

threshold achievement, event

componentsplatelets low, leukocytes low or high, lymphocytes low or high, neutrophils low or high, basophils high, eosinophils high, monocytes high, prothrombin time high, inr high, bilirubin high, indirect bilirubin high, ast high, alt high, gamma gt high, urea nitrogen high, creatinine high, hdl low, ldl high, triglycerides high, potassium abnormal

Secondary/protocol endpoint

Number of Participants With ECG Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)

Time frame:Up to week 28

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With ECG Abnormalities: Cohort 2 (Obesity)

Time frame:Up to week 28

threshold achievement, event

Secondary/protocol endpoint

Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Category: Cohort 2 (Obesity) Only

Time frame:Baseline (result closest prior to dosing on Day 1), anytime post-baseline (Up to Week 28)

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Evaluation of an oral small-molecule glucagon-like peptide-1 receptor agonist, lotiglipron, for type 2 diabetes and obesity: A dose-ranging, phase 2, randomized, placebo-controlled study.
Diabetes, obesity & metabolism2025 Jan (month)PMID39415344doi:10.1111/dom.16005via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.