Taldefgrobep Alfa in Adults With Overweight and Obesity

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

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 Overview

• Status: Active, not recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Taldefgrobep Alfa; Drug: Taldefgrobep Alfa; Drug: Placebo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • Site-001
    • Montclair, California, United States, 97163
      • Site-014
    • Sacramento, California, United States, 95821
      • Site-011
    • Tustin, California, United States, 92780
      • Site-018
  • Florida
    • Orlando, Florida, United States, 32804
      • Site-020
    • Palm Springs, Florida, United States, 33461
      • Site-008
    • St. Petersburg, Florida, United States, 33704
      • Site-015
  • Illinois
    • Chicago, Illinois, United States, 60625
      • Site-007
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • Site-016
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Site-010
    • Metairie, Louisiana, United States, 70006
      • Site-009
  • Missouri
    • City of Saint Peters, Missouri, United States, 63303
      • Site-006
    • Springfield, Missouri, United States, 65807
      • Site-003
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Site-019
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Site-002
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Site-017
  • Texas
    • Austin, Texas, United States, 78745
      • Site-005
    • McKinney, Texas, United States, 75069
      • Site-012
    • San Antonio, Texas, United States, 78229
      • Site-013
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Site-004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taldefgrobep Alpha once weekly	Drug: Taldefgrobep Alfa; Subcutaneous injection administered once each week; Other Names: BHV-2000; Drug: Taldefgrobep Alfa; Subcutaneous injection administered once every 4 weeks; Other Names: BHV-2000
Placebo Comparator: Placebo once weekly	Drug: Placebo; Subcutaneous injection (matching placebo) administered once each week; Drug: Placebo; Subcutaneous injection (matching placebo) administered once every 4 weeks
Experimental: Taldefgrobep Alpha once every 4 weeks	Drug: Taldefgrobep Alfa; Subcutaneous injection administered once each week; Other Names: BHV-2000; Drug: Taldefgrobep Alfa; Subcutaneous injection administered once every 4 weeks; Other Names: BHV-2000
Placebo Comparator: Placebo once every 4 weeks	Drug: Placebo; Subcutaneous injection (matching placebo) administered once each week; Drug: Placebo; Subcutaneous injection (matching placebo) administered once every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in total body weight from Baseline to Week 24	Baseline to Week 24

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Biohaven Therapeutics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: myostatin; activin
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: BHV2000-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No