A Phase 3 interventional study of PF-08653944 and Placebo in Obesity, Overweight and/or Obesity and Overweight, sponsored by Pfizer. Active, not recruiting at 180 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood.
The study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week.
About 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective.
People will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 1,078 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to Screening/Visit 1. T2DM may be treated with:
--Diet and exercise alone or in combination with: Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin
Participants must be motivated and willing to:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive matching placebo by Subcutaneous Injection.
Other: Placebo
Participants will receive PF-08653944 by Subcutaneous Injection.
Drug: PF-08653944
Participants will receive PF-08653944 by Subcutaneous Injection.
Drug: PF-08653944
Participants will receive PF-08653944 by Subcutaneous Injection.
Drug: PF-08653944
By Subcutaneous Injection
Also known as: MET097
By Subcutaneous Injection
Percent Change from baseline in body weight
Time frame: Baseline, Week 64
Change from baseline in body weight
Time frame: Baseline, Week 64 and 84
Change in HbA1c (%) from baseline
Time frame: Baseline, Week 64 and 84
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Time frame: Baseline, Week 64 and 84
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Time frame: Baseline, Week 64 and 84
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Time frame: Baseline, Week 64 and 84
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Time frame: Baseline, Week 64 and 84
Change from baseline in Fasting triglycerides
Time frame: Baseline, Week 64 and 84
Change from baseline in Non-high-density lipoprotein cholesterol (non-HDL-C)
Time frame: Baseline, Week 64 and 84
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 64 and 84
Change from baseline in Short Form 36 health survey (SF-36) physical function domain score
Time frame: Baseline, Week 64 and 84
Percent change from baseline in body weight
Time frame: Baseline, Week 84
Change from baseline in waist circumference
Time frame: Baseline, Week 64 and 84
Percentage of Participants Achieving HbA1c <7%
Time frame: Week 64 and Week 84
Percentage of Participants Achieving HbA1c ≤6.5%
Time frame: Week 64 and Week 84
Percentage of Participants Achieving HbA1c <5.7%
Time frame: Week 64 and Week 84
Change from Baseline in Fasting Glucose
Time frame: Baseline, Week 64 and 84
Change from Baseline in Fasting insulin
Time frame: Baseline, Week 64 and 84
Change from baseline in Total Cholesterol
Time frame: Baseline, Week 64 and 84
Change from baseline in Low-density lipoprotein cholesterol
Time frame: Baseline, Week 64 and 84
Change from baseline in Very low-density lipoprotein cholesterol
Time frame: Baseline, Week 64 and 84
Change from baseline in High-density lipoprotein cholesterol
Time frame: Baseline, Week 64 and 84
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 64 and 84
Percent change from baseline in high-sensitivity C-reactive protein
Time frame: Baseline, Week 64 and 84
Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L)
Time frame: Baseline, Week 64 and 84
Change from Baseline in Control of Eating Questionnaire (CoEQ)
Time frame: Baseline, Week 64 and 84
Change from Baseline in Food Noise Questionnaire (FNQ)
Time frame: Baseline, Week 64 and 84
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Week 84
Number of Participants with Serious adverse events (SAEs)
Time frame: Week 84
Number of Participants with Adverse Events of Clinical Interest (AECIs)
Time frame: Week 84
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Week 84
Number of participants with anti-drug antibodies (ADAs)
Time frame: Week 84
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944
Time frame: Week 84
Showing the first 100 of 180 sites across 11 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Berobenatide