A Phase 3 interventional study of Berobenatide and Placebo in Obesity and Overweight, sponsored by Pfizer. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
Overweight and obesity are long-term health conditions that can increase the possibility of serious health problems. These problems include heart disease, type 2 diabetes (a condition that causes high blood sugar), and other medical conditions. The purpose of this study is to learn whether berobenatide (PF-08653944) is safe and effective for adults in China who are overweight or obese. Researchers will compare berobenatide with a placebo. A placebo looks like study treatment but does not contain active medicine.
About 432 adults will take part in this study. This study is seeking adults who
Participants will be randomly assigned to receive either berobenatide or placebo. Study treatment will be administered as a shot under the skin. All participants will also receive lifestyle counseling throughout the study.
Researchers will monitor participants throughout the study. They will assess participants' body weight, overall health, and any reactions that may occur. During the study, participants will attend study visits and complete study-related assessments.
Participants may take part in the study for up to approximately 59 weeks. This period includes screening, treatment, and follow-up visits. 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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 432 is above the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 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:
Participants will receive matching placebo by Subcutaneous Injection.
Other: Placebo
Participants will receive Berobenatide by Subcutaneous Injection.
Drug: Berobenatide
Participants will receive Berobenatide by Subcutaneous Injection.
Drug: Berobenatide
Participants will receive Berobenatide by Subcutaneous Injection.
Drug: Berobenatide
Participants will receive Berobenatide by Subcutaneous Injection.
Drug: Berobenatide
By Subcutaneous Injection
Also known as: PF-08653944
By Subcutaneous Injection
Percent change from baseline in body weight
Time frame: Baseline, Week 48
Percent change from baseline in body weight in participants without T2D
Time frame: Baseline, Week 48
Change from baseline in body weight
Time frame: Baseline, 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 Fasting triglycerides
Time frame: Baseline, Week 48
Change from baseline in Non-high-density lipoprotein-cholesterol
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 Body mass index (BMI)
Time frame: Baseline, Week 48
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 48
Change from baseline in 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 High-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, Week 48
Change from baseline in Interleukin (IL)-6
Time frame: Baseline, Week 48
Change from baseline in IL-1 beta
Time frame: Baseline, Week 48
Change from Baseline in HbA1c in participants with T2D
Time frame: Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <7.0%
Time frame: Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <6.5%
Time frame: Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <5.7%
Time frame: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT total score
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 EuroQoL5-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
Incidence proportion of Treatment-emergent adverse event (TEAE)
Time frame: Up to Week 55
Incidence proportion of Serious adverse event (SAE)
Time frame: Up to Week 55
Incidence proportion of Adverse event (AE) leading to permanent discontinuation from study intervention or study
Time frame: Up to Week 55
Incidence proportion of Adverse events of special interest (AESIs)
Time frame: Up to Week 55
Incidence proportion of Clinical laboratory abnormalities
Time frame: Up to Week 55
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
Start is estimated for Oct 2026; primary completion for Jun 2028, 19 months later.
Of 176 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 19 months is close to that.
Counting every sponsor, half of 214 studies reached it within 23 months; a quarter within 18 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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 not yet 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