GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese

A PHASE 1, OPEN-LABEL, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF 2 DIFFERENT FORMULATIONS OF PF-07081532 ADMINISTERED ORALLY TO ADULT PARTICIPANTS WHO ARE OVERWEIGHT OR OBESE

Lead sponsor

Pfizer

Asset

Lotiglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 25-34.9•Healthy volunteers

Primary endpoints

•Pharmacokinetics Parameter - AUC to Infinity (AUCinf) of PF-07081532•Pharmacokinetics Parameter - Area Under the Plasma Concentration-Time Profile•Pharmacokinetics Parameter - Cmax of PF-07081532

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 IDNCT05677867

Org study IDC3991010

Timeline

Milestones

Study first posted2023-01-10actual

Study start2023-01-18actual

Primary completion2023-03-14actual

Study completion2023-03-14actual

Last update posted2024-08-09actual

Results first posted2024-08-09actual

Assets

Investigational agents

Lotiglipron

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male and female participants must be at least 18 years of age, inclusive, at the time of signing the ICD

•Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECGs

•Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

•A total body weight >50 kg (110 lb) and BMI of 25.0 to <34.9 kg/m2, inclusive, at the screening visit

•Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and protocol

Exclusion criteria

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)

•Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection)

•History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed

•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2, or pancreatitis, or participants with suspected MTC per the investigator's judgement

•Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study

•Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention

•In females, current use of hormone replacement therapy or oral/injectable contraceptives containing ethinyl estradiol

•Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Investigational products which are strong CYP3A inducers or time-dependent inhibitors are prohibited within 14 days plus 5 half-lives or 30 days (whichever is longer) prior to the dose of study intervention

•Known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-07081532 or known intolerance to a GLP-1R agonist

•A positive urine drug test

•Using a properly sized and calibrated BP cuff, screening supine BP ≥140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility

•Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is >450 ms, this interval should be rate-corrected using the Fridericia method only and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant

•Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:

•Aspartate aminotransferase or alanine aminotransferase level ≥1.25 × upper limit of normal (ULN);

•Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN;

•HbA1c ≥6.5%;

•Fasting blood glucose ≥126 mg/dL (7 mmol/L);

•Calcitonin > ULN;

•eGFR <60 mL/min/1.73 m2 as calculated by the CKD-EPI equation.

Endpoints (14)

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.

Safety / tolerability / PK

14 endpoints

Primary/registry result

Pharmacokinetics Parameter - Area Under the Concentration-Time Curve to Infinity (AUCinf) of PF-07081532

Time frame:Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose on Day 1 of Period 1 and Period 2

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramhour/milliliter (nghr/mL)	95% CI
Formulation A	179400	—
Formulation B	178300	—

Ratio of Adjusted Geometric Means97.4090% CI92.92 – 102.08

Primary/registry result

Pharmacokinetics Parameter - Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532

Time frame:Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose on Day 1 of Period 1 and Period 2

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng*hr/mL	95% CI
Formulation A	171900	—
Formulation B	170400	—

Ratio of Geometric Adjusted Means97.3690% CI92.77 – 102.17

Primary/registry result

Pharmacokinetics Parameter - Maximum Observed Concentration (Cmax) of PF-07081532

Time frame:Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose of Day 1 Period 1 and Period 2.

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogram/milliliter (ng/mL)	95% CI
Formulation A	8072	—
Formulation B	7741	—

Ratio of Adjusted Means94.7090% CI81.40 – 110.18

Primary/protocol endpoint

Pharmacokinetics Parameter - Area Under the Concentration-Time Curve to Infinity (AUCinf) of PF-07081532

Time frame:Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose on Day 1 of Period 1 and Period 2

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics Parameter - Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532

Time frame:Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose on Day 1 of Period 1 and Period 2

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics Parameter - Maximum Observed Concentration (Cmax) of PF-07081532

Time frame:Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post dose of Day 1 Period 1 and Period 2.

Cmax

concentration, descriptive

Secondary/registry result

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All-Causality and Treatment-Related)

Time frame:From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Formulation AAll Causality TEAEs	9	—
Treatment-Related TEAEs	9	—
All-Causality Treatment-Emergent SAE	0	—
Treatment-Related Treatment-Emergent SAE	0	—
Formulation BAll Causality TEAEs	8	—
Treatment-Related TEAEs	8	—
All-Causality Treatment-Emergent SAE	0	—
Treatment-Related Treatment-Emergent SAE	0	—

Secondary/registry result

Number of Participants With Laboratory Abnormalities

Time frame:Baseline (Day 1) up to Period 2 Day 5

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Formulation AMonocytes/Leukocytes (%) > 1.2*ULN	0	—
Urate (mmol/L) > 1.2*ULN	0	—
Formulation BMonocytes/Leukocytes (%) > 1.2*ULN	1	—
Urate (mmol/L) > 1.2*ULN	1	—

Secondary/registry result

Number of Participants Meeting Pre-Specified Criteria of Vital Signs

Time frame:Baseline (Day 1) up to Period 2 Day 5

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Formulation A	0	—
Formulation B	0	—

Secondary/registry result

Number of Participants Meeting Pre-Specified Criteria of Electrocardiogram (ECGs)

Time frame:Baseline (Day 1) up to Period 2 Day 5

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Formulation A	0	—
Formulation B	1	—

Secondary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All-Causality and Treatment-Related)

Time frame:From the first dose up to 28 to 35 days after administration of the final dose of study intervention (maximum of 51 days)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Laboratory Abnormalities

Time frame:Baseline (Day 1) up to Period 2 Day 5

threshold achievement, event

Secondary/protocol endpoint

Number of Participants Meeting Pre-Specified Criteria of Vital Signs

Time frame:Baseline (Day 1) up to Period 2 Day 5

threshold achievement, event

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

Secondary/protocol endpoint

Number of Participants Meeting Pre-Specified Criteria of Electrocardiogram (ECGs)

Time frame:Baseline (Day 1) up to Period 2 Day 5

threshold achievement, event

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.