Tirzepatide + Bimagrumab for Obesity

Overseen By Melanie S Haines, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must be taking: GLP-1 RA

Must not be taking: Anti-obesity, Anabolic agents

Disqualifiers: Diabetes, Chronic kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of drugs, tirzepatide and bimagrumab, to help people with obesity lose weight by reducing fat while maintaining muscle and bone health. The researchers aim to determine if this combination is more effective than using either drug alone, alongside lifestyle changes for weight loss. It targets adults who have previously tried to lose weight without success and have a BMI of 30 or higher, or 27 with a weight-related health issue. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using certain medications like anti-obesity drugs, weight gain-inducing drugs, and muscle anabolic agents. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using tirzepatide and bimagrumab together can be safe. Studies have found that tirzepatide is generally well-tolerated and has a safety profile similar to other weight loss treatments. Many people using tirzepatide experience significant weight loss with few side effects.

Bimagrumab has also been studied for weight loss, primarily reducing body fat while preserving muscle mass. Some studies suggest an average weight loss of 6.5%, mostly from fat, indicating it may effectively target fat without causing many side effects.

When used together, tirzepatide and bimagrumab are being tested for safety and effectiveness. Early findings suggest they can aid weight loss by reducing fat and preserving muscle. While more research is needed to confirm these results, initial studies look promising.

For those considering joining a clinical trial with these treatments, this information suggests a reasonable expectation of safety. However, discussing any concerns with a healthcare professional before participating is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for obesity, like lifestyle changes and medications such as orlistat, phentermine, or GLP-1 receptor agonists, focus on reducing appetite or limiting fat absorption. But this new combination of tirzepatide and bimagrumab works differently by not only helping with weight loss but also preserving muscle mass. Tirzepatide is a GLP-1 and GIP receptor agonist that helps with weight loss by controlling blood sugar and reducing appetite, while bimagrumab is a monoclonal antibody that targets and blocks a protein called activin type II receptor, which helps maintain muscle mass during weight loss. Researchers are excited because this dual-action approach could lead to healthier weight loss by ensuring muscle is not lost along with fat, potentially offering a more balanced and effective treatment for obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research shows that using tirzepatide and bimagrumab together might help treat obesity by reducing fat while preserving muscle. In this trial, some participants will receive the combination of tirzepatide and bimagrumab. Studies indicate that bimagrumab alone, another treatment arm in this trial, results in weight loss entirely from fat, with a 2.5% increase in muscle. Tirzepatide, also studied as a separate treatment arm, has enabled many people to lose 20% or more of their body weight. Combining these treatments is expected to enhance fat loss and maintain muscle, potentially improving overall health for people with obesity. These findings suggest this treatment combination could lead to better weight management and health outcomes. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with obesity, defined as having a BMI of at least 30 or at least 27 with a weight-related medical condition. Participants should have tried to lose weight unsuccessfully before. It's not specified who can't join the trial.

Inclusion Criteria

Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight

My BMI is 30 or higher, or it's 27 or higher with a weight-related health issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide and/or bimagrumab in addition to a lifestyle intervention for weight loss

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bimagrumab
• Tirzepatide

Trial Overview

The study tests if Tirzepatide and Bimagrumab, either alone or combined, affect body fat, muscle mass, bone health, and insulin sensitivity in obese adults over one year. All participants receive lifestyle and nutrition counseling plus Calcium/Vitamin D supplements.

How Is the Trial Designed?

Group I: Tirzepatide + bimagrumab Experimental Treatment 4 Interventions

Group II: Bimagrumab + placebo Active Control 3 Interventions

Group III: Tirzepatide + placebo Active Control 3 Interventions

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06901349

NCT06901349 | A Study of Bimagrumab (LY3985863) and ...

The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants ...

2.

diabetes.org

diabetes.org/newsroom/press-releases/new-glp-1-therapies-enhance-quality-weight-loss-improving-muscle-0

New GLP-1 Therapies Enhance Quality of Weight Loss by ...

Notably, with the use of bimagrumab alone, 100% of weight loss was attributed to fat mass and there was an increase of 2.5% total lean mass. " ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11913498/

Paradigm shift in obesity treatment: an extensive review of ...

In the SURMOUNT-3 trial, tirzepatide showed a clinically significant additional decrease in body weight among overweight or obese patients after integrating ...

4.

dom-pubs.onlinelibrary.wiley.com

dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.70229

Challenges and promising outcomes for fat loss and ...

The study concluded that patients treated with bimagrumab experienced an average weight loss of 6.5%, primarily consisting of a 20.5% reduction ...

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/14656566.2024.2436595

Tirzepatide for overweight and obesity management

Tirzepatide marks a new era in overweight/obesity treatment, enabling many to achieve ≥ 20% weight loss. It is well-tolerated with a safety profile similar to ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06643728

NCT06643728 | A Study to Investigate Weight ...

The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or ...