Not yet recruitingPhase 3

A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly 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-MONTHLY 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

432

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥28

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 IDNCT07874633

Org study IDC6491029

Timeline

Milestones

Study first posted2026-10-15actual

Study start2026-10-15estimated

Last update posted2026-10-15actual

Primary completion2028-06-06estimated

Study completion2028-08-15estimated

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 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.

•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 (40)

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)

Safety / tolerability / PK

Patient-reported / QoL

Weight & body composition

10 endpoints

Primary/protocol endpoint

Percent change from baseline in body weight

Time frame:Baseline, Week 48

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight in participants without T2D

Time frame:Baseline, Week 48

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:Baseline, 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

7 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

Change from Baseline in HbA1c in participants with T2D

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:Baseline, Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of participants with T2D at screening achieving HbA1c <6.5%

Time frame:Baseline, Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of participants with T2D at screening achieving HbA1c <5.7%

Time frame:Baseline, Week 48

threshold achievement, improvement

Cardiometabolic biomarkers

9 endpoints

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 Non-high-density lipoprotein-cholesterol

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 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 High-sensitivity C-reactive protein (hs-CRP)

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 EuroQoL5-Dimension 5-Level (EQ-5D-5L) index score

Time frame:Baseline, Week 48

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Incidence proportion of Treatment-emergent adverse event (TEAE)

Time frame:Up to Week 55

threshold achievement, event

Secondary/protocol endpoint

Incidence proportion of Serious adverse event (SAE)

Time frame:Up to Week 55

threshold achievement, event

Secondary/protocol endpoint

Incidence proportion of Adverse event (AE) leading to permanent discontinuation from study intervention or study

Time frame:Up to Week 55

threshold achievement, event

Secondary/protocol endpoint

Incidence proportion of Adverse events of special interest (AESIs)

Time frame:Up to Week 55

threshold achievement, event

Secondary/protocol endpoint

Incidence proportion of Clinical laboratory abnormalities

Time frame:Up to Week 55

threshold achievement, event

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

Change from baseline in Interleukin (IL)-6

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in IL-1 beta

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in IWQoL-Lite-CT total score

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.