Clinical trial

Taldefgrobep Alfa in Adults With Overweight and Obesity

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT07281495

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Overweight

Full registry 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

Treatments and study arms

Taldefgrobep Alfa

Drug

Subcutaneous injection administered once each week

Placebo

Drug

Subcutaneous injection (matching placebo) administered once each week

Taldefgrobep Alfa

Drug

Subcutaneous injection administered once every 4 weeks

Placebo

Drug

Subcutaneous injection (matching placebo) administered once every 4 weeks

Primary outcomes

Percent change in total body weight from Baseline to Week 24Baseline to Week 24

Study locations

20 locations were listed when this page was built. The first 40 are shown.

Site-004🇺🇸 Arlington, Virginia, United States