臨床研究等提出・公開システム

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6) (VESPER-6)

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity (VESPER-6)

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Recruiting

Aug. 07, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

*Aged >=18 years.
*BMI of: >=30 kg/m2 or >=27.0 kg/m2 to <30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.

*Have a self-reported body weight change greater than 5% within 90 days prior to Screening.
*Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.
*History of acute or chronic pancreatitis.
*Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).

Both

Obesity, Overweight and/or Obesity, Overweight

*Drug: PF-08653944
-By Subcutaneous Injection
*Other: Placebo
-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 events leading to discontinuation [Time Frame: Baseline, Week 72]
*Number of Participants with Adverse Events of Special Interest (AESIs) [Time Frame: Baseline, Week 72]

+81-6-6395-9000

July. 10, 2026

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.

United States