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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
197
Subcutaneous Injection
Subcutaneous Injection
Oishi Clinic
Kasuya-gun, Fukuoka, Japan
Manda Memorial Hospital
Sapporo, Hokkaido, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, Japan
Tokyo Center Clinic
Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Shimamura Memorial Hospital
Nerima-ku, Tokyo, Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, Japan
Higashi-Shinjuku Clinic, Keikokai Medical Corp.
Shinjuku-ku, Tokyo, Japan
Ikebukuro Metropolitan Clinic
Toshima-ku, Tokyo, Japan
...and 1 more locations
Percent 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 ≥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 achieving ≥5% of body weight reduction from baseline
Time frame: Baseline, Week 72
Change from baseline in body weight
Time frame: Baseline, Week 72
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 72
Change from baseline in Diastolic Blood Pressure (DBP)
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
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 fasting glucose
Time frame: Baseline, 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
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Week 72
Number of participants with Serious Adverse Events (SAEs)
Time frame: Week 72
Number of participants with adverse events leading to discontinuation
Time frame: Week 72
Number of participants with Adverse Events of Special Interest (AESIs)
Time frame: Week 72
Number of participants with absolute and change from baseline in laboratory measurements
Time frame: Week 72
Change from baseline in visceral fat area
Time frame: Baseline, Week 72
Percentage of participants achieving visceral fat area <100 cm2
Time frame: Week 72
Percentage of participants achieving the conversion to normoglycemia
Time frame: Week 72
Change from baseline in Oral Glucose Tolerance Test (OGTT) 2h
Time frame: Baseline, Week 72
Percentage of participants achieving conversion from HbA1c ≥7% to HbA1c <7%
Time frame: Week 72
Percentage of participants achieving conversion from HbA1c ≥5.7% to HbA1c <5.7%
Time frame: Week 72
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