A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
PF-08653944
DrugBy Subcutaneous Injection
Placebo
Other interventionBy Subcutaneous Injection
Treatment groups
954 Participants
are divided into 5 treatment groupsGroup A: Treatment Arm 1Experimental treatment 1 intervention
Group B: Treatment Arm 2Experimental treatment 1 intervention
Group C: Treatment Arm 3Experimental treatment 1 intervention
Group D: Treatment Arm 4Experimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent change from baseline in body weight
Time frame
Baseline, Week 72Secondary outcomes
1
Change from baseline in body weight
Time frame
Baseline, Week 722
Change from baseline in waist circumference
Time frame
Baseline, Week 723
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Time frame
Baseline, Week 724
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Time frame
Baseline, Week 72 Source ClinicalTrials.gov