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NCT Number: NCT07281495

Taldefgrobep Alfa in Adults With Overweight and Obesity

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site-001, Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Taldefgrobep Alfa

Drug

Subcutaneous injection administered once each week

Other names: BHV-2000

Placebo

Drug

Subcutaneous injection (matching placebo) administered once each week

Primary outcomes

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

    Time frame: Baseline to Week 24

Secondary outcomes

  1. Percent change in total body fat mass from Baseline to Week 24

    Time frame: Baseline to Week 24

  2. Percent change in total body lean mass from Baseline to Week 24

    Time frame: Baseline to Week 24

  3. Number of participants with death, SAEs, AEs considered related to study drug, moderate and severe AEs, and Grade 3 to 4 laboratory abnormalities

    Time frame: Through week 24

Sponsors and collaborators

Lead sponsor

Biohaven Therapeutics Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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