NCT07281495
Active, not recruiting
Phase 2
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study With Open-Label Extension to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Taldefgrobep Alfa in Adults Living With Overweight and Obesity
Biohaven Therapeutics Ltd.35 sites in 1 country150 target enrollmentStarted: November 24, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Biohaven Therapeutics Ltd.
- Enrollment
- 150
- Locations
- 35
- Primary Endpoint
- Percent change in total body weight from Baseline to Week 24
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Taldefgrobep Alpha once weekly
Experimental
Intervention: Taldefgrobep Alfa (Drug)
Placebo once weekly
Placebo Comparator
Intervention: Placebo (Drug)
Taldefgrobep Alpha once every 4 weeks
Experimental
Intervention: Taldefgrobep Alfa (Drug)
Placebo once every 4 weeks
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent change in total body weight from Baseline to Week 24
Time Frame: Baseline to Week 24
Secondary Outcomes
- 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)
Investigators
Study Sites (35)
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