GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY

Lead sponsor

Pfizer

Asset

Danuglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

628

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Cohorts 1 and 2•Cohort 3•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04707313

Org study IDC3421019

Secondary ID2020-001312-19

Timeline

Milestones

Study first posted2021-01-13actual

Study start2021-01-29actual

Primary completion2023-09-13actual

Study completion2023-10-11actual

Results first posted2024-10-09actual

Last update posted2024-11-05actual

Assets

Investigational agents

Danuglipron

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2

•Stable body weight, defined as <5 kg change (per participant report) for 90 days before visit 1

Exclusion criteria

•Any condition possibly affecting drug absorption

•Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of diabetes

•History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months prior to visit 1

•Any malignancy not considered cured

•Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 or suspected MTC

•History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any history of chronic pancreatitis

•Symptomatic gallbladder disease

•Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders

•History of major depressive disorder or other severe psychiatric disorders within the last 2 years

•Any lifetime history of a suicide attempt

•Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis

•Known history of HIV

•Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)

•Clinically relevant ECG abnormalities

•Positive urine drug screen

•Participation in a formal weight reduction program within 90 days prior to visit 1

Endpoints (52)

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

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

20 endpoints

Primary/registry result

Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26

Time frame:Baseline, Week 26

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Cohorts 1 and 2: Placebo	0.17	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)	-5.43	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)	-4.83	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)	-8.94	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)	-6.43	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)	-9.36	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)	-6.96	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)	-8.96	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)	-7.02	—

Difference to placebo-5.6090% CI-7.41 – -3.74p<.0001Mixed Models Analysis

Difference to placebo-5.0090% CI-6.80 – -3.16p<.0001Mixed Models Analysis

Difference to Placebo-9.1090% CI-10.89 – -7.28p<.0001Mixed Models Analysis

Difference to Placebo-6.6090% CI-8.75 – -4.39p<.0001Mixed Models Analysis

Difference to Placebo-9.5290% CI-11.43 – -7.56p<.0001Mixed Models Analysis

Difference to Placebo-7.1290% CI-9.41 – -4.78p<.0001Mixed Models Analysis

Difference to Placebo-9.1290% CI-11.11 – -7.08p<.0001Mixed Models Analysis

Difference to Placebo-7.1890% CI-9.32 – -4.99p<.0001Mixed Models Analysis

Primary/registry result

Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32

Time frame:Baseline, Week 32

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Cohort 3: Placebo	1.40	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)	-6.92	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)	-7.15	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)	-11.65	—

Difference to Placebo-8.2190% CI-11.66 – -4.63p<.0001Mixed Models Analysis

Difference to placebo-8.4490% CI-11.83 – -4.92p<.0001Mixed Models Analysis

Difference to Placebo-12.8790% CI-16.15 – -9.47p<.0001Mixed Models Analysis

Primary/protocol endpoint

Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26

Time frame:Baseline, Week 26

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32

Time frame:Baseline, Week 32

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Cohorts 1 and 2: Number of Participants With >= 5% Body Weight Loss at End of Treatment

Time frame:Week 26

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohorts 1 and 2: Placebo	6	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)	16	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)	15	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)	17	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)	12	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)	15	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)	6	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)	12	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)	8	—

Odds Ratio (OR)7.3790% CI2.81 – 19.30

Odds Ratio (OR)6.5890% CI2.62 – 16.53

Odds Ratio (OR)16.3390% CI6.47 – 41.24

Odds Ratio (OR)14.2490% CI5.39 – 37.66

Odds Ratio (OR)30.1790% CI11.35 – 80.20

Odds Ratio (OR)9.8890% CI2.91 – 33.53

Odds Ratio (OR)24.4190% CI8.28 – 71.95

Odds Ratio (OR)12.6590% CI4.56 – 35.08

Secondary/registry result

Cohort 3: Number of Participants With >=5% Body Weight Loss at End of Treatment

Time frame:Week 32

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohort 3: Placebo	0	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)	9	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)	11	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)	10	—

Odds Ratio (OR)33.4390% CI3.05 – 366.64

Odds Ratio (OR)34.0490% CI3.10 – 373.85

Odds Ratio (OR)127.2190% CI10.55 – 1533.46

Secondary/registry result

Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22

Time frame:Baseline, Weeks 2, 4, 6, 8, 10, 12,16, 18, 22

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Cohorts 1 and 2: PlaceboWeek 2	-0.13	—
Week 4	-0.15	—
Week 6	-0.24	—
Week 8	-0.41	—
Week 10	-0.50	—
Week 12	-0.44	—
Week 16	-0.40	—
Week 18	-0.50	—
Week 22	-0.18	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)Week 2	-0.85	—
Week 4	-1.65	—
Week 6	-2.26	—
Week 8	-2.93	—
Week 10	-3.47	—
Week 12	-3.89	—
Week 16	-4.73	—
Week 18	-4.94	—
Week 22	-5.06	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)Week 2	-0.54	—
Week 4	-1.69	—
Week 6	-2.37	—
Week 8	-2.86	—
Week 10	-3.33	—
Week 12	-3.88	—
Week 16	-4.01	—
Week 18	-4.68	—
Week 22	-5.00	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)Week 2	-0.98	—
Week 4	-1.99	—
Week 6	-2.96	—
Week 8	-3.89	—
Week 10	-4.82	—
Week 12	-5.31	—
Week 16	-6.98	—
Week 18	-7.33	—
Week 22	-8.10	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)Week 2	-0.58	—
Week 4	-1.26	—
Week 6	-1.99	—
Week 8	-3.33	—
Week 10	-3.92	—
Week 12	-4.49	—
Week 16	-5.49	—
Week 18	-6.33	—
Week 22	-6.43	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)Week 2	-0.87	—
Week 4	-1.71	—
Week 6	-2.84	—
Week 8	-3.87	—
Week 10	-4.67	—
Week 12	-5.66	—
Week 16	-7.04	—
Week 18	-7.50	—
Week 22	-8.63	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)Week 2	-0.22	—
Week 4	-0.93	—
Week 6	-1.93	—
Week 8	-2.34	—
Week 10	-3.20	—
Week 12	-3.98	—
Week 16	-5.15	—
Week 18	-5.57	—
Week 22	-6.57	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)Week 2	-0.96	—
Week 4	-1.98	—
Week 6	-2.97	—
Week 8	-3.83	—
Week 10	-4.54	—
Week 12	-5.33	—
Week 16	-6.56	—
Week 18	-7.27	—
Week 22	-8.23	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)Week 2	-0.53	—
Week 4	-1.28	—
Week 6	-1.99	—
Week 8	-2.94	—
Week 10	-3.83	—
Week 12	-4.34	—
Week 16	-5.18	—
Week 18	-5.80	—
Week 22	-6.60	—

Secondary/registry result

Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28

Time frame:Baseline, Weeks 4, 8, 12, 16, 20, 24 and 28

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent Change	95% CI
Cohort 3: PlaceboWeek 4	-0.37	—
Week 8	-0.06	—
Week 12	-0.08	—
Week 16	0.03	—
Week 20	0.38	—
Week 24	0.36	—
Week 28	1.06	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)Week 4	-1.38	—
Week 8	-2.07	—
Week 12	-2.80	—
Week 16	-4.13	—
Week 20	-5.17	—
Week 24	-5.65	—
Week 28	-6.37	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)Week 4	-0.95	—
Week 8	-1.93	—
Week 12	-2.88	—
Week 16	-3.99	—
Week 20	-5.25	—
Week 24	-6.39	—
Week 28	-6.74	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)Week 4	-1.02	—
Week 8	-1.89	—
Week 12	-2.96	—
Week 16	-4.73	—
Week 20	-7.10	—
Week 24	-9.20	—
Week 28	-10.44	—

Secondary/registry result

Cohorts 1 and 2: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 26

Time frame:Baseline, Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Centimeter	95% CI
Cohorts 1 and 2: Placebo	-1.25	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)	-6.49	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)	-5.75	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)	-6.19	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)	-5.98	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)	-9.05	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)	-7.41	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)	-7.56	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)	-6.36	—

Secondary/registry result

Cohort 3: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 32

Time frame:Baseline, Week 32

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Centimeter	95% CI
Cohort 3: Placebo	0.19	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)	-6.27	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)	-7.77	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)	-11.43	—

Secondary/registry result

Cohorts 1 and 2: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 26

Time frame:Baseline, Week 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Ratio	95% CI
Cohorts 1 and 2: Placebo	-0.002	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)	-0.002	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)	-0.015	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)	0.001	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)	-0.014	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)	-0.015	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)	-0.014	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)	-0.007	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)	0.004	—

Secondary/registry result

Cohort 3: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 32

Time frame:Baseline, Week 32

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Ratio	95% CI
Cohort 3: Placebo	0.010	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)	-0.012	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)	-0.009	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)	-0.016	—

Secondary/protocol endpoint

Cohorts 1 and 2: Number of Participants With >= 5% Body Weight Loss at End of Treatment

Time frame:Week 26

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Cohort 3: Number of Participants With >=5% Body Weight Loss at End of Treatment

Time frame:Week 32

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22

Time frame:Baseline, Weeks 2, 4, 6, 8, 10, 12,16, 18, 22

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28

Time frame:Baseline, Weeks 4, 8, 12, 16, 20, 24 and 28

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Cohorts 1 and 2: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 26

Time frame:Baseline, Week 26

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Cohort 3: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 32

Time frame:Baseline, Week 32

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Cohorts 1 and 2: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 26

Time frame:Baseline, Week 26

change from baseline, improvement

Secondary/protocol endpoint

Cohort 3: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 32

Time frame:Baseline, Week 32

change from baseline, improvement

Glycemic / diabetes

8 endpoints

Secondary/registry result

Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26

Time frame:Baseline, Weeks 16 and 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
Cohorts 1 and 2: PlaceboWeek 16	0.00	—
Week 26	0.01	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)Week 16	-0.24	—
Week 26	-0.17	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)Week 16	-0.24	—
Week 26	-0.13	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)Week 16	-0.26	—
Week 26	-0.22	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)Week 16	-0.25	—
Week 26	-0.16	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)Week 16	-0.29	—
Week 26	-0.31	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)Week 16	-0.18	—
Week 26	-0.13	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)Week 16	-0.23	—
Week 26	-0.17	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)Week 16	-0.24	—
Week 26	-0.26	—

Secondary/registry result

Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32

Time frame:Baseline, Weeks 16, 24 and 32

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
Cohort 3: PlaceboWeek 16	-0.05	—
Week 24	0.05	—
Week 32	-0.02	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)Week 16	-0.16	—
Week 24	-0.13	—
Week 32	-0.11	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)Week 16	-0.26	—
Week 24	-0.21	—
Week 32	-0.27	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)Week 16	-0.29	—
Week 24	-0.31	—
Week 32	-0.41	—

Secondary/registry result

Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26

Time frame:Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Milligram per deciliter	95% CI
Cohorts 1 and 2: PlaceboWeek 2	3.22	—
Week 4	3.38	—
Week 6	1.45	—
Week 8	1.61	—
Week 10	2.47	—
Week 12	2.57	—
Week 16	0.50	—
Week 18	4.34	—
Week 22	4.83	—
Week 26	3.34	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)Week 2	-2.93	—
Week 4	-2.75	—
Week 6	-4.28	—
Week 8	-3.72	—
Week 10	-2.52	—
Week 12	-2.70	—
Week 16	-2.67	—
Week 18	-0.44	—
Week 22	0.38	—
Week 26	-3.37	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)Week 2	-2.56	—
Week 4	-2.97	—
Week 6	-2.29	—
Week 8	-3.15	—
Week 10	-1.79	—
Week 12	-0.77	—
Week 16	-2.04	—
Week 18	-3.73	—
Week 22	-3.22	—
Week 26	-3.43	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)Week 2	-4.02	—
Week 4	-3.59	—
Week 6	-6.38	—
Week 8	-2.56	—
Week 10	-4.74	—
Week 12	-2.24	—
Week 16	-2.56	—
Week 18	0.19	—
Week 22	-4.27	—
Week 26	-4.02	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)Week 2	-2.02	—
Week 4	-0.83	—
Week 6	-4.17	—
Week 8	-2.77	—
Week 10	-2.60	—
Week 12	-1.22	—
Week 16	-6.99	—
Week 18	-0.96	—
Week 22	-1.78	—
Week 26	-3.75	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)Week 2	-4.51	—
Week 4	-4.81	—
Week 6	-3.46	—
Week 8	-4.48	—
Week 10	-4.17	—
Week 12	-4.86	—
Week 16	-6.62	—
Week 18	-4.76	—
Week 22	-2.03	—
Week 26	-6.00	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)Week 2	-1.16	—
Week 4	-2.56	—
Week 6	-3.06	—
Week 8	-4.07	—
Week 10	-5.26	—
Week 12	-4.65	—
Week 16	-5.73	—
Week 18	-5.23	—
Week 22	-1.65	—
Week 26	-3.50	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)Week 2	-2.82	—
Week 4	-6.24	—
Week 6	-4.32	—
Week 8	-4.90	—
Week 10	-5.35	—
Week 12	-3.01	—
Week 16	-4.67	—
Week 18	0.11	—
Week 22	-4.64	—
Week 26	-6.60	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)Week 2	-2.93	—
Week 4	-3.86	—
Week 6	-4.64	—
Week 8	-2.82	—
Week 10	-2.85	—
Week 12	-3.19	—
Week 16	-5.24	—
Week 18	0.53	—
Week 22	-5.08	—
Week 26	-5.01	—

Secondary/registry result

Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32

Time frame:Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Milligram per deciliter	95% CI
Cohort 3: PlaceboWeek 4	-1.82	—
Week 8	0.10	—
Week 12	-1.28	—
Week 16	-5.75	—
Week 20	1.52	—
Week 24	-2.80	—
Week 28	1.67	—
Week 32	-1.81	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)Week 4	-0.83	—
Week 8	1.79	—
Week 12	-1.80	—
Week 16	-5.18	—
Week 20	-1.95	—
Week 24	-0.13	—
Week 28	-0.15	—
Week 32	1.28	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)Week 4	0.96	—
Week 8	-1.16	—
Week 12	1.56	—
Week 16	-2.43	—
Week 20	-4.78	—
Week 24	-2.00	—
Week 28	-4.53	—
Week 32	-1.65	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)Week 4	3.84	—
Week 8	2.52	—
Week 12	-0.42	—
Week 16	0.88	—
Week 20	-1.39	—
Week 24	1.62	—
Week 28	0.90	—
Week 32	-1.73	—

Secondary/protocol endpoint

Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26

Time frame:Baseline, Weeks 16 and 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32

Time frame:Baseline, Weeks 16, 24 and 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26

Time frame:Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32

Time frame:Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Patient-reported / QoL

1 endpoint

Secondary/registry result

Cohort 1 and 2: Number of Participants With Scores on the Patient Health Questionnaire-9 (PHQ-9) Leading to Study Discontinuation

Time frame:Week 0 (Baseline) , 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohorts 1 and 2: Placebo	0	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)	0	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)	0	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)	0	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)	0	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)	0	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)	0	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)	0	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)	0	—

Safety / tolerability / PK

23 endpoints

Secondary/registry result

Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 31 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohorts 1 and 2: PlaceboTEAEs	50	—
TESAEs	1	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)TEAEs	52	—
TESAEs	2	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)TEAEs	59	—
TESAEs	1	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)TEAEs	54	—
TESAEs	0	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)TEAEs	32	—
TESAEs	1	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)TEAEs	59	—
TESAEs	1	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)TEAEs	30	—
TESAEs	0	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)TEAEs	59	—
TESAEs	5	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)TEAEs	30	—
TESAEs	1	—

Secondary/registry result

Cohort 3: Number of Participants With TEAEs and TESAEs

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 37 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohort 3: PlaceboTEAEs	13	—
TESAEs	0	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)TEAEs	30	—
TESAEs	2	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)TEAEs	34	—
TESAEs	2	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)TEAEs	34	—
TESAEs	3	—

Secondary/registry result

Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohorts 1 and 2: Placebo	66	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)	56	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)	60	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)	57	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)	37	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)	54	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)	33	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)	59	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)	33	—

Secondary/registry result

Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohort 3: Placebo	15	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)	31	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)	34	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)	32	—

Secondary/registry result

Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohorts 1 and 2: PlaceboSBP Value < 90	0	—
DBP Value < 50	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)SBP Value < 90	0	—
DBP Value < 50	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)SBP Value < 90	1	—
DBP Value < 50	1	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)SBP Value < 90	0	—
DBP Value < 50	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)SBP Value < 90	1	—
DBP Value < 50	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)SBP Value < 90	2	—
DBP Value < 50	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)SBP Value < 90	1	—
DBP Value < 50	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)SBP Value < 90	0	—
DBP Value < 50	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)SBP Value < 90	0	—
DBP Value < 50	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—

Secondary/registry result

Cohort 3: Number of Participants According to Categorization of Vital Signs Data

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohort 3: PlaceboDBP Value < 50	0	—
SBP Value < 90	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)DBP Value < 50	0	—
SBP Value < 90	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)DBP Value < 50	1	—
SBP Value < 90	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)DBP Value < 50	0	—
SBP Value < 90	0	—
PR <40 beats per minute	0	—
PR >120 beats per minute	0	—

Secondary/registry result

Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohorts 1 and 2: PlaceboQRS interval >=140	0	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)QRS interval >=140	0	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)QRS interval >=140	1	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)QRS interval >=140	0	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)QRS interval >=140	0	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)QRS interval >=140	1	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)QRS interval >=140	0	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)QRS interval >=140	0	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)QRS interval >=140	0	—
QTCF interval >500	0	—
PR interval >=300	0	—

Secondary/registry result

Cohort 3: Number of Participants According to Categorization of ECG Parameters

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohort 3: PlaceboQRS interval >=140	0	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)QRS interval >=140	0	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)QRS interval >=140	0	—
QTCF interval >500	0	—
PR interval >=300	0	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)QRS interval >=140	1	—
QTCF interval >500	0	—
PR interval >=300	0	—

Secondary/registry result

Cohorts 1 and 2: Number of Participants With Categorical Scores on Columbia-Suicide Severity Rating Scale (C-SSRS) Leading to Study Discontinuation

Time frame:Week 0 (Baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohorts 1 and 2: Placebo	0	—
Cohort 1: PF-06882961 40mg BID (1-week Titration)	0	—
Cohort 1: PF-06882961 80mg BID (1-week Titration)	0	—
Cohort 1: PF-06882961 120mg BID (1-week Titration)	0	—
Cohorts 1 and 2: PF-06882961 120 mg BID (2-week Titration)	0	—
Cohort 1: PF-06882961 160 mg BID (1-week Titration)	0	—
Cohorts 1 and 2: PF-06882961 160 mg BID (2-week Titration)	0	—
Cohort 1: PF-06882961 200 mg BID (1-week Titration)	0	—
Cohorts 1 and 2: PF-06882961 200 mg BID (2-week Titration)	0	—

Secondary/registry result

Cohort 3: Number of Participants With Categorical Scores on C-SSRS Leading to Study Discontinuation

Time frame:Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohort 3: Placebo	0	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)	0	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)	0	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)	0	—

Secondary/registry result

Cohort 3: Number of Participants With Scores on the PHQ-9 Leading to Study Discontinuation

Time frame:Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Cohort 3: Placebo	0	—
Cohort 3: PF-06882961 80mg BID (4-week Titration)	0	—
Cohort 3: PF-06882961 140mg BID (4-week Titration)	0	—
Cohort 3: PF-06882961 200mg BID (4-week Titration)	0	—

Secondary/protocol endpoint

Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 31 weeks)

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Cohort 3: Number of Participants With TEAEs and TESAEs

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 37 weeks)

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)

event count, event

Secondary/protocol endpoint

Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)

descriptive

Secondary/protocol endpoint

Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)

threshold achievement, event

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

Secondary/protocol endpoint

Cohort 3: Number of Participants According to Categorization of Vital Signs Data

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)

threshold achievement, event

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

Secondary/protocol endpoint

Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)

descriptive

Secondary/protocol endpoint

Cohort 3: Number of Participants According to Categorization of ECG Parameters

Time frame:From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)

threshold achievement, event

Secondary/protocol endpoint

Cohorts 1 and 2: Number of Participants With Categorical Scores on Columbia-Suicide Severity Rating Scale (C-SSRS) Leading to Study Discontinuation

Time frame:Week 0 (Baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)

event count, event

Secondary/protocol endpoint

Cohort 3: Number of Participants With Categorical Scores on C-SSRS Leading to Study Discontinuation

Time frame:Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Cohort 1 and 2: Number of Participants With Scores on the Patient Health Questionnaire-9 (PHQ-9) Leading to Study Discontinuation

Time frame:Week 0 (Baseline) , 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Cohort 3: Number of Participants With Scores on the PHQ-9 Leading to Study Discontinuation

Time frame:Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)

Discontinuation due to AE

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

Efficacy and safety of danuglipron (PF-06882961) in adults with obesity: A randomized, placebo-controlled, dose-ranging phase 2b study.
Diabetes, obesity & metabolism2025 Sep (month)PMID40539310doi:10.1111/dom.16534via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.