Obesity / Overweight / Berobenatide · Phase 3 Trial

A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity

ClinicalTrials.gov · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered Phase 3 randomized controlled trial of berobenatide (a GLP-1 receptor agonist analogue) versus placebo in Chinese adults with overweight or obesity. The study has not yet begun recruitment and no efficacy or safety results are available. The registration documents the planned primary endpoint of percent change in body weight from baseline to Week 48.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Obesity, Overweight; age from 18 Years. Intervention: Berobenatide Low Maintenance Dose; Berobenatide Medium Maintenance Dose; Berobenatide High Maintenance Dose. Compared with: Placebo Matched to Low-Dose Berobenatide — Placebo Comparator; Placebo Matched to Medium-Dose Berobenatide — Placebo Comparator; Placebo Matched to High-Dose Berobenatide — Placebo Comparator. n = 300. 33 sites: China.

Key findings

Planned primary outcome: Percent change from baseline in body weight at Week 48 Planned enrollment: 300 participants (estimated) Study population: Chinese adults with obesity or overweight with or without type 2 diabetes and weight-related comorbidities

Safety

No efficacy, safety, or adverse event data are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registered Phase 3 trial not yet recruiting with no results posted; it represents a planned study with defined primary endpoints but no outcome data to evaluate.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Percent Change From Baseline in Body Weight at Week 48 (assessed at Baseline to Week 48)

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationObesity, Overweight; age from 18 Years

Sample size300

InterventionBerobenatide Low Maintenance Dose; Berobenatide Medium Maintenance Dose; Berobenatide High Maintenance Dose

ComparatorPlacebo Matched to Low-Dose Berobenatide — Placebo Comparator; Placebo Matched to Medium-Dose Berobenatide — Placebo Comparator; Placebo Matched to High-Dose Berobenatide — Placebo Comparator

Setting33 sites: China

Reported figures

Quoted from the source exactly as published.

Planned sample size300

Primary outcome measurePercent change from baseline in body weight at Week 48

Study duration48 weeks

Caveats

This is a registry record only; no results have been posted or are available in this source.
Recruitment has not yet begun; enrollment status listed as NOT_YET_RECRUITING.
Details on study procedures, visit frequency, dosing schedule, and follow-up duration are noted as to be explained by the study team but are not fully detailed in this registry summary.
No efficacy, safety, or adverse event data are reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3, randomized, placebo-controlled interventional trial design.

Directness

strong

Primary endpoint is percent change in body weight at Week 48, a clinically relevant measure.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Study not yet recruiting; conduct, blinding, and implementation details not yet available.

Sample adequacy

moderate

Planned enrollment 300 participants, estimated; adequate for Phase 3 but subject to recruitment.

Source abstract

Registry record from ClinicalTrials.gov (NCT07792954). This is a study registration, not published results. Lead sponsor: Pfizer. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Obesity, Overweight. Interventions: DRUG: Berobenatide; OTHER: Placebo. Primary outcome measures: Percent Change From Baseline in Body Weight at Week 48 , Baseline to Week 48. Brief 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityOverweightBerobenatideNCT07792954Pfizer