Taldefgrobep Alfa for Obesity

Recruiting at 12 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biohaven Therapeutics Ltd.

Disqualifiers: Diabetes, Non-ambulatory, Pregnant, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called taldefgrobep alfa, an experimental drug, to determine if it can help individuals with overweight or obesity lose weight safely and effectively. The study compares different dosing schedules of the treatment against a placebo, a harmless pill with no effect, to identify the best option. Individuals who have unsuccessfully tried to lose weight through dieting and maintain a stable weight and activity level might be suitable candidates. Participants must have a BMI over 30, or between 27 and 30 if they have a weight-related health issue. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that taldefgrobep alfa is likely to be safe for humans?

Research has shown that taldefgrobep alfa has been tested in several studies for various health conditions. In studies involving patients with spinal muscular atrophy (SMA), the treatment led to positive changes in body fat and movement abilities, suggesting good tolerance. However, it did not meet all its objectives in those trials.

Currently, taldefgrobep alfa is in a Phase 2 trial for obesity, indicating that earlier Phase 1 tests demonstrated sufficient safety for broader testing. Although detailed safety information for this specific trial is limited, passing initial safety checks is promising. Prospective participants should discuss potential risks with healthcare providers before joining any trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Taldefgrobep Alfa is unique because it targets obesity differently from most current treatments. While typical obesity medications often focus on appetite suppression or fat absorption, Taldefgrobep Alfa works by modulating muscle growth pathways, potentially increasing muscle mass and boosting metabolism. Researchers are excited about the potential for this mechanism to offer a new approach to managing obesity, especially for patients who have not responded well to existing treatments. Additionally, the treatment offers flexibility in administration, with options for weekly or monthly dosing, which could improve patient compliance and convenience.

What evidence suggests that taldefgrobep alfa might be an effective treatment for obesity?

Research shows that taldefgrobep alfa might aid weight management by altering body composition. Studies have found that this treatment can reduce body fat while increasing muscle and bone strength. In healthy adults, it significantly increased thigh muscle size. These changes suggest the treatment can enhance overall body health and may assist with weight loss. In this trial, participants will receive taldefgrobep alfa either once weekly or once every four weeks, or a placebo on the same schedules. Although more research is needed specifically for obesity, these early results are encouraging. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with overweight and obesity issues. Specific details about who can join or reasons why someone might not be allowed to participate are not provided here.

Inclusion Criteria

My BMI is between 27 and 42, and if it's between 27 and 30, I also have a weight-related health issue.

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

Exclusion Criteria

I have diabetes or my blood sugar levels are high.

I cannot walk 10 steps on my own.

I am not pregnant, breastfeeding, nor planning to become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive taldefgrobep alfa or placebo in a double-blind, placebo-controlled manner

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment with taldefgrobep alfa long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Taldefgrobep Alfa

Trial Overview

The study tests taldefgrobep alfa against a placebo in a controlled environment, where participants don't know which one they're getting. The goal is to see if it's effective, safe, and tolerable for treating obesity over multiple doses.

How Is the Trial Designed?

Group I: Taldefgrobep Alpha once weekly Experimental Treatment 1 Intervention

Group II: Taldefgrobep Alpha once every 4 weeks Experimental Treatment 1 Intervention

Group III: Placebo once weekly Placebo Group 1 Intervention

Group IV: Placebo once every 4 weeks Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+

Citations

1.

ir.biohaven.com

ir.biohaven.com/news-releases/news-release-details/biohaven-provides-update-taldefgrobep-alfa-development-program

Biohaven Provides Update on Taldefgrobep Alfa ...

In the RESILIENT SMA study, taldefgrobep alpha showed clinically meaningful improvements in motor function at all timepoints on the Motor Function Measurement- ...

2.

smauk.org.uk

smauk.org.uk/treatments-research/drugs-being-tested-clinical-trials/taldefgrobep-alfa-biohaven-resilient-trial-results-and-updates/

Taldefgrobep Alfa (Biohaven) RESILIENT Trial Results and ...

Participants receiving taldefgrobep alfa showed a decrease in body fat, increases in lean muscle mass and bone strength compared to those who ...

3.

prnewswire.com

prnewswire.com/news-releases/biohaven-provides-update-on-taldefgrobep-alfa-development-program-for-spinal-muscular-atrophy-and-obesity-302314979.html

Biohaven Provides Update on Taldefgrobep Alfa ...

The favorable effects observed on overall body composition (fat and lean mass) is consistent with nonclinical data showing that taldefgrobep has ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10787703/

The Clinical Development of Taldefgrobep Alfa: An Anti ...

In healthy adult volunteers, taldefgrobep alfa was generally well tolerated and resulted in a significant increase in thigh muscle volume.

5.

neurologylive.com

neurologylive.com/view/taldefgrobep-alpha-yields-encouraging-subgroup-signals-despite-missing-key-endpoints-sma-trial

Taldefgrobep Alpha Yields Encouraging Subgroup Signals ...

The study also found that taldefgrobep significantly reduced total body fat mass compared with placebo + SOC at week 48 (P = .008), as measured ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07281495

Taldefgrobep Alfa in Adults With Overweight and Obesity

Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.