The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes. About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe. People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
954
By Subcutaneous Injection
By Subcutaneous Injection
San Fernando Valley Health Institute
Canoga Park, California, United States
RECRUITINGHeadlands Research California, LLC
Escondido, California, United States
RECRUITINGImmuniMet, LLC
Modesto, California, United States
RECRUITINGClinical Trials Research
Sacramento, California, United States
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 avents leading to discontinuation
Time frame: Baseline, Week 72
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Baseline, Week 72
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