A Phase 3 interventional study of PF-08653944 and Placebo in Obesity, Overweight and/or Obesity and Overweight, sponsored by Pfizer. Recruiting at 80 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
Spain, France, Germany, Italy, Mexico, Poland
The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.
About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.
People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 954 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.
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.
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.
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.
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
Participants will receive PF-08653944 by Subcutaneous Injection.
Drug: PF-08653944
Participants will receive matching placebo by Subcutaneous Injection.
Other: Placebo
By Subcutaneous Injection
By Subcutaneous Injection
Percent change from baseline in body weight
Time frame: Baseline, Week 72
Change from baseline in body weight
Time frame: Baseline, Week 72
Change from baseline in waist circumference
Time frame: Baseline, Week 72
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Time frame: Baseline, Week 72
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Time frame: Baseline, Week 72
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Time frame: Baseline, Week 72
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Time frame: Baseline, Week 72
Percentage of Participants with a waist-to-height ratio of <0.53
Time frame: Baseline, Week 72
Percent change from baseline in body weight in participants with type 2 diabetes
Time frame: Baseline, Week 72
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 72
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 72
Percentage of Participants achieving ≥25% of body weight reduction from baseline
Time frame: Baseline, Week 72
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 72
Change from Baseline in Fasting Glucose
Time frame: Basline, Week 72
Change from Baseline in Fasting insulin
Time frame: Baseline, Week 72
Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)
Time frame: Baseline, Week 72
Change from Baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B)
Time frame: Baseline, Week 72
Change from Baseline in HbA1c
Time frame: Baseline, Week 72
Change from baseline in Fasting Total Cholesterol
Time frame: Baseline, Week 72
Change from baseline in Fasting Low-density lipoprotein cholesterol
Time frame: Baseline, Week 72
Change from baseline in Fasting Very low-density lipoprotein cholesterol
Time frame: Baseline, Week 72
Change from baseline in Fasting Non-High-density lipoprotein cholesterol
Time frame: Baseline, Week 72
Change from baseline in Fasting High-density lipoprotein cholesterol
Time frame: Baseline, Week 72
Change from baseline in Fasting triglycerides
Time frame: Baseline, Week 72
Change from baseline in high-sensitivity C-reactive protein
Time frame: Baseline, Week 72
Change from baseline in interleukin-6
Time frame: Baseline, Week 72
Change from baseline in interleukin-1 beta
Time frame: Baseline, Week 72
Change from baseline in IWQoL-Lite-CT total score
Time frame: Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Physical composite score
Time frame: Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Psychosocial composite score
Time frame: Baseline, Week 72
Change from baseline in Short Form 36 health survey (SF-36) domain scales and component summary scales
Time frame: Baseline, Week 72
Change from Baseline in Control of Eating Questionnaire (CoEQ) subscales
Time frame: Baseline, Week 72
Change from Baseline in Food Noise Questionnaire (FNQ) total score
Time frame: Baseline, Week 72
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline, Week 72
Number of Participants with Serious adverse events (SAEs)
Time frame: Baseline, Week 72
Number of Participants with adverse avents leading to discontinuation
Time frame: Baseline, Week 72
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Baseline, Week 72
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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
Started Jun 2026 (actual). Primary completion is estimated for May 2028, 22 months after the start.
Of 198 industry-sponsored phase 3 interventional studies under Obesity, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 27. This study's planned 22 months is close to that.
Counting every sponsor, half of 261 studies reached it within 24 months; a quarter within 18 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
Spain, France, Germany, Italy, Mexico, Poland
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 ↗
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Studies of the drug tested here: Berobenatide