ObesityPhase 3NCT07792954
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity
A Phase 3 study testing Berobenatide in people with Obesity and Overweight, run by Pfizer at 34 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Berobenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 34 sitesChina
- Study dates
- 24 Sep 2026to 23 May 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age.
- BMI ≥28 kg/m²; or BMI ≥24 kg/m² and <28 kg/m² with at least one weight-related comorbidity.
- Participants with T2D must have HbA1c 6.5% to 10.0%.
- At least one prior unsuccessful dietary weight-loss attempt.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
China34 sites, 34 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
- Not yet recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
- Not yet recruiting
Beijing Pinggu Hospital
Beijing, Beijing Municipality, 101200
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
- Not yet recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130022
- Not yet recruiting
Changzhou Second People's Hospital
Changzhou, Jiangsu, 213164
- Not yet recruiting
Chongqing People's Hospital
Chongqing, Chongqing Municipality, 400013
- Not yet recruiting
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000
- Not yet recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
- Not yet recruiting
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
- Not yet recruiting
The Second People's Hospital of Hefei
Hefei, Anhui, 230011
- Not yet recruiting
Harrison International Peace Hospital
Hengshui, Hebei, 053000
- Not yet recruiting
Huizhou Central People's Hospital
Huizhou, Guangdong, 516001
- Not yet recruiting
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
- Not yet recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
- Recruiting
Luoyang First People's Hospital
Luoyang, Henan, 471000
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471023
- Not yet recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330038
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
- Not yet recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210012
- Not yet recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
- Not yet recruiting
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, 315010
- Not yet recruiting
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000
- Not yet recruiting
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200032
- Not yet recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
- Not yet recruiting
The Fifth People's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200240
- Not yet recruiting
Pudong New Area People's Hospital Shanghai
Shanghai, Shanghai Municipality, 201299
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
- Not yet recruiting
Shiyan Taihe Hospital
Shiyan, Hubei, 442000
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
- Not yet recruiting
Wuhan Third Hospital
Wuhan, Hubei, 430060
- Not yet recruiting
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi, 400016
- Not yet recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
- Not yet recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001
About this study
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-WEEKLY PF-08653944 IN CHINESE ADULTS WITH OVERWEIGHT OR OBESITY
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.
Read more
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.
- Conditions
- Obesity, Overweight
- Being tested
- Berobenatide, Placebo
- Keywords
- Obesity, Overweight, Weight Management, Weight Reduction, Body Weight, Chronic Weight Management, Adults With Obesity, Adults With Overweight
- Medical subject headings
- Obesity, Overweight, Weight Loss, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerobenatideDrug
Also called PF-08653944
Solution for injection
PlaceboOther
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Berobenatide Medium Maintenance Dose | Experimental | Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a medium maintenance dose during the maintenance phase. Receives: Drug: Berobenatide |
| Placebo Matched to Low-Dose Berobenatide | Placebo comparator | Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase. Receives: Other: Placebo |
| Berobenatide Low Maintenance Dose | Experimental | Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a low maintenance dose during the maintenance phase. Receives: Drug: Berobenatide |
| Berobenatide High Maintenance Dose | Experimental | Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a high maintenance dose during the maintenance phase. Receives: Drug: Berobenatide |
| Placebo Matched to Medium-Dose Berobenatide | Placebo comparator | Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase. Receives: Other: Placebo |
| Placebo Matched to High-Dose Berobenatide | Placebo comparator | Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight at Week 48
Measured: Baseline to Week 48
Secondary outcomes (32)
Change From Baseline in Body Weight at Week 48
Measured: Baseline to Week 48
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Measured: Baseline, Week 48
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Measured: Baseline, Week 48
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Measured: Baseline, Week 48
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Measured: Baseline, Week 48
Change from baseline in waist circumference
Measured: Baseline, Week 48
Change from baseline in Non-High-density lipoprotein cholesterol
Measured: Baseline, Week 48
Change from baseline in Fasting triglycerides
Measured: Baseline, Week 48
Change from baseline in Systolic Blood Pressure (SBP)
Measured: Baseline, Week 48
Change from baseline in Short Form 36 health survey (SF-36) Physical Function domain score
Measured: Baseline, Week 48
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score
Measured: Baseline, Week 48
Change from baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline, Week 48
Change from baseline in Fasting Total Cholesterol
Measured: Baseline, Week 48
Change from baseline in Low-density lipoprotein cholesterol
Measured: Baseline, Week 48
Change from baseline in Very low-density lipoprotein cholesterol
Measured: Baseline, Week 48
Change from baseline in High-density lipoprotein cholesterol
Measured: Baseline, Week 48
Change from Baseline in HbA1c
Measured: Baseline, Week 48
Change from baseline in Fasting Plasma Glucose
Measured: Baseline, Week 48
Change from baseline in Fasting Insulin
Measured: Baseline, Week 48
Change from baseline in hs-CRP (high-sensitivity C-reactive protein)
Measured: Baseline, Week 48
Change from baseline in Interleukin-6 (IL-6)
Measured: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Physical Composite
Measured: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Psychosocial Composite
Measured: Baseline, Week 48
Change from baseline in SF-36 domain scales and component summary scales
Measured: Baseline, Week 48
Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score
Measured: Baseline, Week 48
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)
Measured: Baseline, Week 48
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Week 58
Number of participants with Serious Adverse Events (SAE)
Measured: Up to Week 58
Number of participants with AE leading to permanent discontinuation from study intervention or study
Measured: Up to Week 58
Percentage of participants with T2D at screening achieving HbA1c <7.0%
Measured: Up to Week 48
Percentage of participants with Type 2 diabetes (T2D) at screening achieving HbA1c <5.7%
Measured: Up to Week 48
Change from Baseline in Body mass index (BMI)
Measured: Baseline, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start24 Sep 2026
- Primary completion14 Mar 2028 (estimated)
- Study completion23 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792954
- Sponsor's protocol ID
- C6491018
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.