Altus Research | Women's Health Studies
Status and phase
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About
A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women
Full description
This study investigates if bimagrumab in addition to semaglutide is able to preserve/increase muscle mass in the presence of weight and/or fat mass loss.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
A written informed consent must be obtained before any study-related assessments are performed.
Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:
Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)
Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg
Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight
Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
507 participants in 9 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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