Overview
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.
Eligibility
Key Inclusion Criteria:
- 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
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- Stable body weight and stable physical activity within 3 months prior to screening per participant self-report.
- All participants must adhere to protocol contraception requirements
Key Exclusion Criteria:
- History of diabetes, including individuals with a HbA1c of ≥ 6.5% at Screening
- Non-ambulatory participants, defined as unable to take at least 10 steps independently.
- Females currently pregnant or breastfeeding, or who intend to become pregnant or to breastfeed.
- Participation in another investigational clinical trial while participating in this clinical trial