RecruitingPhase 3

A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-WEEKLY PF-08653944 IN CHINESE ADULTS WITH OVERWEIGHT OR OBESITY

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

300

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥28•HbA1c 6.5-10%

Primary endpoint

•Body Weight

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 IDNCT07792954

Org study IDC6491018

Timeline

Milestones

Study first posted2026-08-28actual

Study start2026-09-24actual

Last update posted2026-11-05actual

Primary completion2028-03-14estimated

Study completion2028-05-23estimated

Assets

Investigational agents

MET097 / PF-08653944

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Adults ≥18 years of age.

•BMI ≥28 kg/m²; or BMI ≥24 kg/m² and <28 kg/m² with at least one weight-related comorbidity.

•Participants with T2D must have HbA1c 6.5% to 10.0%.

•At least one prior unsuccessful dietary weight-loss attempt.

Exclusion criteria

•Significant recent weight change (>5% within 3 months).

•Type 1 diabetes mellitus.

•History of pancreatitis.

•Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple endocrine neoplasia type 2 (MEN2).

•Recent bariatric surgery or obesity procedures.

•Pregnancy or breastfeeding.

Endpoints (33)

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

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Other (unclassified)

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

9 endpoints

Primary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 48

Time frame:Baseline to Week 48

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 48

Time frame:Baseline to Week 48

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants achieving ≥5% of body weight reduction from baseline

Time frame:Baseline, Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants achieving ≥10% of body weight reduction from baseline

Time frame:Baseline, Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants achieving ≥15% of body weight reduction from baseline

Time frame:Baseline, Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants achieving ≥20% of body weight reduction from baseline

Time frame:Baseline, Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body mass index (BMI)

Time frame:Baseline, Week 48

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting Plasma Glucose

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting Insulin

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Percentage of participants with T2D at screening achieving HbA1c <7.0%

Time frame:Up to Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of participants with Type 2 diabetes (T2D) at screening achieving HbA1c <5.7%

Time frame:Up to Week 48

threshold achievement, improvement

Cardiometabolic biomarkers

9 endpoints

Secondary/protocol endpoint

Change from baseline in Non-High-density lipoprotein cholesterol

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting triglycerides

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting Total Cholesterol

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Low-density lipoprotein cholesterol

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Very low-density lipoprotein cholesterol

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in High-density lipoprotein cholesterol

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in hs-CRP (high-sensitivity C-reactive protein)

Time frame:Baseline, Week 48

change from baseline, improvement

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

Change from baseline in Short Form 36 health survey (SF-36) Physical Function domain score

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in SF-36 domain scales and component summary scales

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score

Time frame:Baseline, Week 48

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of participants with Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to Week 58

event count, event

Secondary/protocol endpoint

Number of participants with Serious Adverse Events (SAE)

Time frame:Up to Week 58

event count, event

Secondary/protocol endpoint

Number of participants with AE leading to permanent discontinuation from study intervention or study

Time frame:Up to Week 58

event count, event

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Change from baseline in Interleukin-6 (IL-6)

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in IWQoL-Lite-CT Physical Composite

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in IWQoL-Lite-CT Psychosocial Composite

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)

Time frame:Baseline, Week 48

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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 November 5, 2026 snapshot.