MedDataX Logo

Taldefgrobep Alfa in Adults With Overweight and Obesity

NCT ID: NCT07281495

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Overweight

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

myostatin activin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Taldefgrobep Alpha once weekly

Group Type EXPERIMENTAL

Taldefgrobep Alfa

Intervention Type DRUG

Subcutaneous injection administered once each week

Placebo once weekly

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous injection (matching placebo) administered once each week

Taldefgrobep Alpha once every 4 weeks

Group Type EXPERIMENTAL

Taldefgrobep Alfa

Intervention Type DRUG

Subcutaneous injection administered once every 4 weeks

Placebo once every 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous injection (matching placebo) administered once every 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Taldefgrobep Alfa

Subcutaneous injection administered once each week

Intervention Type DRUG

Placebo

Subcutaneous injection (matching placebo) administered once each week

Intervention Type DRUG

Taldefgrobep Alfa

Subcutaneous injection administered once every 4 weeks

Intervention Type DRUG

Placebo

Subcutaneous injection (matching placebo) administered once every 4 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BHV-2000 BHV-2000

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biohaven Therapeutics Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site-001

Chula Vista, California, United States

Site Status RECRUITING

Site-011

Sacramento, California, United States

Site Status RECRUITING

Site-008

Palm Springs, Florida, United States

Site Status RECRUITING

Site-007

Chicago, Illinois, United States

Site Status RECRUITING

Site-016

Indianapolis, Indiana, United States

Site Status RECRUITING

Site-009

Metairie, Louisiana, United States

Site Status RECRUITING

Site-006

City of Saint Peters, Missouri, United States

Site Status RECRUITING

Site-003

Springfield, Missouri, United States

Site Status RECRUITING

Site-002

Fargo, North Dakota, United States

Site Status RECRUITING

Site-005

Austin, Texas, United States

Site Status RECRUITING

Site-012

McKinney, Texas, United States

Site Status RECRUITING

Site-013

San Antonio, Texas, United States

Site Status RECRUITING

Site-004

Arlington, Virginia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chief Medical Officer

Role: CONTACT

Phone: 203-404-0410

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BHV2000-202

Identifier Type: -

Identifier Source: org_study_id