NCT07281495

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
4mo left

Started Nov 2025

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Nov 2025Sep 2026

Study Start

First participant enrolled

November 24, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

December 4, 2025

Last Update Submit

March 19, 2026

Conditions

ObesityOverweight

Keywords

myostatinactivin

Outcome Measures

Primary Outcomes (1)

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

    Baseline to Week 24

Secondary Outcomes (3)

  • 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

Study Arms (4)

Taldefgrobep Alpha once weekly

EXPERIMENTAL
Drug: Taldefgrobep Alfa

Placebo once weekly

PLACEBO COMPARATOR
Drug: Placebo

Taldefgrobep Alpha once every 4 weeks

EXPERIMENTAL
Drug: Taldefgrobep Alfa

Placebo once every 4 weeks

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Taldefgrobep AlfaDRUG

Subcutaneous injection administered once each week

Also known as: BHV-2000
Taldefgrobep Alpha once weekly
PlaceboDRUG

Subcutaneous injection (matching placebo) administered once each week

Placebo once weekly

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Site-001

Chula Vista, California, 91911, United States

Location

Site-014

Montclair, California, 97163, United States

Location

Site-011

Sacramento, California, 95821, United States

Location

Site-018

Tustin, California, 92780, United States

Location

Site-020

Orlando, Florida, 32804, United States

Location

Site-008

Palm Springs, Florida, 33461, United States

Location

Site-015

St. Petersburg, Florida, 33704, United States

Location

Site-007

Chicago, Illinois, 60625, United States

Location

Site-016

Indianapolis, Indiana, 46254, United States

Location

Site-010

Baton Rouge, Louisiana, 70808, United States

Location

Site-009

Metairie, Louisiana, 70006, United States

Location

Site-006

City of Saint Peters, Missouri, 63303, United States

Location

Site-003

Springfield, Missouri, 65807, United States

Location

Site-019

Monroe, North Carolina, 28112, United States

Location

Site-002

Fargo, North Dakota, 58104, United States

Location

Site-017

North Charleston, South Carolina, 29405, United States

Location

Site-005

Austin, Texas, 78745, United States

Location

Site-012

McKinney, Texas, 75069, United States

Location

Site-013

San Antonio, Texas, 78229, United States

Location

Site-004

Arlington, Virginia, 22205, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 15, 2025

Study Start

November 24, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

US(20)