Obesity, Overweight
Conditions
Keywords
Obesity, Overweight, Weight Management, Weight Reduction, Body Weight, Chronic Weight Management, Adults With Obesity, Adults With Overweight
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.
Interventions
DRUGBerobenatide
Solution for injection
OTHERPlacebo
Solution for injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Body Weight at Week 48 | Baseline to Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score | Baseline, Week 48 |
| Change from baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 48 |
| Change from baseline in Fasting Total Cholesterol | Baseline, Week 48 |
| Change from baseline in Low-density lipoprotein cholesterol | Baseline, Week 48 |
| Change from baseline in Very low-density lipoprotein cholesterol | Baseline, Week 48 |
| Change from baseline in High-density lipoprotein cholesterol | Baseline, Week 48 |
| Change from Baseline in HbA1c | Baseline, Week 48 |
| Change from baseline in Fasting Plasma Glucose | Baseline, Week 48 |
| Change from baseline in Fasting Insulin | Baseline, Week 48 |
| Change from baseline in hs-CRP (high-sensitivity C-reactive protein) | Baseline, Week 48 |
| Change from baseline in Interleukin-6 (IL-6) | Baseline, Week 48 |
| Change from baseline in IWQoL-Lite-CT Physical Composite | Baseline, Week 48 |
| Change from baseline in IWQoL-Lite-CT Psychosocial Composite | Baseline, Week 48 |
| Change from baseline in SF-36 domain scales and component summary scales | Baseline, Week 48 |
| Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score | Baseline, Week 48 |
| Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS) | Baseline, Week 48 |
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | Up to Week 58 |
| Number of participants with Serious Adverse Events (SAE) | Up to Week 58 |
| Number of participants with AE leading to permanent discontinuation from study intervention or study | Up to Week 58 |
| Percentage of participants with T2D at screening achieving HbA1c <7.0% | Up to Week 48 |
| Percentage of participants with Type 2 diabetes (T2D) at screening achieving HbA1c <5.7% | Up to Week 48 |
| Change from Baseline in Body mass index (BMI) | Baseline, Week 48 |
| Change From Baseline in Body Weight at Week 48 | Baseline to Week 48 |
| Percentage of Participants achieving ≥5% of body weight reduction from baseline | Baseline, Week 48 |
| Percentage of Participants achieving ≥10% of body weight reduction from baseline | Baseline, Week 48 |
| Percentage of Participants achieving ≥15% of body weight reduction from baseline | Baseline, Week 48 |
| Percentage of Participants achieving ≥20% of body weight reduction from baseline | Baseline, Week 48 |
| Change from baseline in waist circumference | Baseline, Week 48 |
| Change from baseline in Non-High-density lipoprotein cholesterol | Baseline, Week 48 |
| Change from baseline in Fasting triglycerides | Baseline, Week 48 |
| Change from baseline in Short Form 36 health survey (SF-36) Physical Function domain score | Baseline, Week 48 |
| Change from baseline in Systolic Blood Pressure (SBP) | Baseline, Week 48 |
Countries
China
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed