Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
954 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for adults with overweight or obesity who may also have type 2 diabetes. Participants will get either a shot of the study medicine, berobenatide, or a placebo that doesn't contain any medicine. The study lasts for about 20 months and involves regular visits to check on health and weight.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesPancreatitisMedullary thyroid carcinoma
You may be able to join if
I am at least 18 years old.
My BMI is 27.0 kg/m2 or higher with weight-related health issues.
My BMI is 30 kg/m2 or higher.
You may not be able to join if
I have had a weight change greater than 5% in the last 90 days.
I have type 1 diabetes or another type of diabetes.
I have had pancreatitis.
I have a personal or family history of medullary thyroid carcinoma.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Bero…
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.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Have a self-reported body we…
Inclusion Criteria:
* 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.
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).
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