Obesity, Overweight
Conditions
Keywords
myostatin, activin
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled, multiple dose study to evaluate the efficacy, safety, and tolerability of taldefgrobep alfa in adults with overweight and obesity, with an open-label extension.
Interventions
Subcutaneous injection administered once each week
DRUGPlacebo
Subcutaneous injection (matching placebo) administered once each week
Sponsors
Biohaven Therapeutics Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. a. BMI \> 30 kg/m2 and BMI \< 42 kg/m2, OR b. BMI ≥ 27 kg/m2 and BMI \<30 kg/m2 with at least one weight-related co-morbidity 2. History of at least one self-reported unsuccessful dietary effort to lose body weight. 3. Stable body weight and stable physical activity within 3 months prior to screening per participant self-report. 4. All participants must adhere to protocol contraception requirements Key
Exclusion criteria
1. History of diabetes, including individuals with a HbA1c of ≥ 6.5% at Screening 2. Non-ambulatory participants, defined as unable to take at least 10 steps independently. 3. Females currently pregnant or breastfeeding, or who intend to become pregnant or to breastfeed. 4. Participation in another investigational clinical trial while participating in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in total body weight from Baseline to Week 24 | Baseline to Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in total body fat mass from Baseline to Week 24 | Baseline to Week 24 |
| Percent change in total body lean mass from Baseline to Week 24 | Baseline to Week 24 |
| Number of participants with death, SAEs, AEs considered related to study drug, moderate and severe AEs, and Grade 3 to 4 laboratory abnormalities | Through week 24 |
Countries
United States
Outcome results
None listed