A Phase 3 interventional study of Berobenatide and Placebo in Obesity and Overweight, sponsored by Pfizer. Recruiting at 34 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
Overweight and obesity are long-term health conditions that can increase the risk of serious health problems, including heart disease, type 2 diabetes, and other medical conditions.
The purpose of this study is to learn whether berobenatide is safe and effective for adults in China who have overweight or obesity. Researchers will compare berobenatide with a placebo, which looks like the study treatment but does not contain active medicine.
People may be able to participate if they are adults with obesity or if they have overweight together with certain weight-related health conditions. Some participants may also have type 2 diabetes. Specific eligibility requirements will be reviewed by the study doctor before enrollment.
Participants will be randomly assigned to receive either berobenatide or placebo. The study treatment will be administered according to the study protocol, and participants will be monitored throughout the study to assess changes in body weight and overall health, as well as any side effects that may occur.
During participation, participants will attend study visits and complete study-related assessments. Researchers will collect information about participants' health, body weight, and safety throughout the study. Details about the number of visits, study duration, and study procedures will be explained by the study team before participation.
The information learned from this study may help researchers better understand whether berobenatide could be a treatment option for adults living with overweight or obesity.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 300 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.
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.
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.
Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a medium maintenance dose during the maintenance phase.
Drug: Berobenatide
Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.
Other: Placebo
Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a low maintenance dose during the maintenance phase.
Drug: Berobenatide
Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a high maintenance dose during the maintenance phase.
Drug: Berobenatide
Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.
Other: Placebo
Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.
Other: Placebo
Solution for injection
Also known as: PF-08653944
Solution for injection
Percent Change From Baseline in Body Weight at Week 48
Time frame: Baseline to Week 48
Change From Baseline in Body Weight at Week 48
Time frame: Baseline to Week 48
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Time frame: Baseline, Week 48
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Time frame: Baseline, Week 48
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Time frame: Baseline, Week 48
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Time frame: Baseline, Week 48
Change from baseline in waist circumference
Time frame: Baseline, Week 48
Change from baseline in Non-High-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from baseline in Fasting triglycerides
Time frame: Baseline, Week 48
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 48
Change from baseline in Short Form 36 health survey (SF-36) Physical Function domain score
Time frame: Baseline, Week 48
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 in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 48
Change from baseline in Fasting Total Cholesterol
Time frame: Baseline, Week 48
Change from baseline in Low-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from baseline in Very low-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from baseline in High-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from Baseline in HbA1c
Time frame: Baseline, Week 48
Change from baseline in Fasting Plasma Glucose
Time frame: Baseline, Week 48
Change from baseline in Fasting Insulin
Time frame: Baseline, Week 48
Change from baseline in hs-CRP (high-sensitivity C-reactive protein)
Time frame: Baseline, Week 48
Change from baseline in Interleukin-6 (IL-6)
Time frame: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Physical Composite
Time frame: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Psychosocial Composite
Time frame: Baseline, Week 48
Change from baseline in SF-36 domain scales and component summary scales
Time frame: Baseline, Week 48
Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score
Time frame: Baseline, Week 48
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: Baseline, Week 48
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 58
Number of participants with Serious Adverse Events (SAE)
Time frame: Up to Week 58
Number of participants with AE leading to permanent discontinuation from study intervention or study
Time frame: Up to Week 58
Percentage of participants with T2D at screening achieving HbA1c <7.0%
Time frame: Up to Week 48
Percentage of participants with Type 2 diabetes (T2D) at screening achieving HbA1c <5.7%
Time frame: Up to Week 48
Change from Baseline in Body mass index (BMI)
Time frame: Baseline, Week 48
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 ↗
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Studies of the drug tested here: Berobenatide