Obesity
Conditions
Keywords
obesity, overweight, obesity disease
Brief summary
The purpose of this clinical study is to learn about safety and effects of berobenatide (PF-08653944) in adults with obesity disease, a condition in which a person has too much body fat, which can harm their health and increase the risk of other medical problems. Some participants in this study may also have type 2 diabetes, a condition in which the body does not use insulin properly, causing blood sugar levels to become too high. This study is seeking participants in Japan who: * Have obesity disease. * May have type 2 diabetes. * Meet the study-specific age, weight, and health requirements. About 197 adults will take part in this study. Participants will be randomly assigned to receive either berobenatide or a placebo. A placebo looks like the study medicine but does not contain any active medicine. Berobenatide or placebo will be given as an injection under the skin of the abdomen (belly area). The study will compare the experiences of people receiving berobenatide with those receiving placebo to determine whether berobenatide can help people lose weight. The study will also assess the safety of berobenatide and its effects on body weight and other health measures. People will take part in this study for about 21 months. During this time, they will have about 16 study visits at the site. They will also have 2 study visits over the phone.
Interventions
DRUGBerobenatide
Subcutaneous Injection
OTHERPlacebo
Subcutaneous Injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years. * BMI of: ≥27.0 kg/m2 to \<35.0 kg/m2 with ≥2 obesity-related health disorders or BMI of ≥35.0 kg/m2 with ≥1 obesity-related health disorder. The participant must have at least one of either hypertension, dyslipidemia or glucose intolerance (T2D and impaired glucose tolerance etc.) as an obesity-related health disorder.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in body weight | Baseline, Week 72 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in IWQoL-Lite-CT total score | Baseline, Week 72 |
| Change from baseline in IWQoL-Lite-CT Physical composite score | Baseline, Week 72 |
| Change from baseline in IWQoL-Lite-CT Psychosocial composite score | Baseline, Week 72 |
| Change from baseline in fasting glucose | Baseline, Week 72 |
| Change from baseline in fasting insulin | Baseline, Week 72 |
| Change from baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S) | Baseline, Week 72 |
| Change from baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B) | Baseline, Week 72 |
| Change from baseline in HbA1c | Baseline, Week 72 |
| Change from baseline in fasting total cholesterol | Baseline, Week 72 |
| Change from baseline in fasting low-density lipoprotein cholesterol | Baseline, Week 72 |
| Change from baseline in fasting very low-density lipoprotein cholesterol | Baseline, Week 72 |
| Change from baseline in fasting non-high-density lipoprotein cholesterol | Baseline, Week 72 |
| Change from baseline in fasting high-density lipoprotein cholesterol | Baseline, Week 72 |
| Change from baseline in fasting triglycerides | Baseline, Week 72 |
| Change from baseline in high-sensitivity C-reactive protein | Baseline, Week 72 |
| Change from baseline in interleukin-6 | Baseline, Week 72 |
| Change from baseline in interleukin-1 beta | Baseline, Week 72 |
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | Week 72 |
| Number of participants with Serious Adverse Events (SAEs) | Week 72 |
| Number of participants with adverse events leading to discontinuation | Week 72 |
| Number of participants with Adverse Events of Special Interest (AESIs) | Week 72 |
| Number of participants with absolute and change from baseline in laboratory measurements | Week 72 |
| Change from baseline in visceral fat area | Baseline, Week 72 |
| Percentage of participants achieving visceral fat area <100 cm2 | Week 72 |
| Percentage of participants achieving the conversion to normoglycemia | Week 72 |
| Change from baseline in Oral Glucose Tolerance Test (OGTT) 2h | Baseline, Week 72 |
| Percentage of participants achieving conversion from HbA1c ≥7% to HbA1c <7% | Week 72 |
| Percentage of participants achieving conversion from HbA1c ≥5.7% to HbA1c <5.7% | Week 72 |
| Change from baseline in body weight | Baseline, Week 72 |
| Change from baseline in Systolic Blood Pressure (SBP) | Baseline, Week 72 |
| Change from baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 72 |
| Percentage of participants achieving ≥10% of body weight reduction from baseline | Baseline, Week 72 |
| Percentage of participants achieving ≥15% of body weight reduction from baseline | Baseline, Week 72 |
| Percentage of participants achieving ≥20% of body weight reduction from baseline | Baseline, Week 72 |
| Percentage of participants achieving ≥5% of body weight reduction from baseline | Baseline, Week 72 |
| Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score | Baseline, Week 72 |
| Change from baseline in waist circumference | Baseline, Week 72 |
Countries
Japan
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed