Bimagrumab + Tirzepatide for Obesity with Type 2 Diabetes

No longer recruiting at 51 trial locations

Overseen By Bonnie Kimmel

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss drugs

Disqualifiers: Type 1 diabetes, Hypertension, Cardiovascular, Renal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 13 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of bimagrumab and tirzepatide, alone or combined, in aiding weight loss for individuals with obesity and type 2 diabetes. Researchers aim to determine the safety and efficacy of these treatments in reducing body weight. Participants will receive different combinations of bimagrumab, tirzepatide, or placebos (inactive substances) over approximately 13 months. Suitable candidates for this trial include those with type 2 diabetes, a body mass index (BMI) of 27 or higher, and no significant weight changes in the past three months. As a Phase 2 trial, this research focuses on evaluating 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 must stop taking your current medications, but it excludes those who have taken medications that cause significant weight gain or promote weight loss within 3 months prior to screening.

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

Research has shown that bimagrumab is generally safe for people with obesity. In past studies, patients who used bimagrumab for 48 weeks did not experience major safety issues, and most tolerated it well without serious side effects.

Similarly, studies on tirzepatide indicate it is safe for people with type 2 diabetes and obesity. Tirzepatide is already approved for managing diabetes and weight, confirming its safety for these purposes. In these studies, most participants handled tirzepatide without major problems.

Overall, both bimagrumab and tirzepatide have demonstrated promising safety in earlier research, suggesting they are generally well tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because bimagrumab and tirzepatide offer unique approaches for managing obesity in people with type 2 diabetes. Bimagrumab is intriguing because it targets and blocks the activin type II receptor, which may help reduce body fat and build muscle simultaneously — something standard diabetes treatments do not typically do. Tirzepatide, on the other hand, is a dual agonist that activates both GIP and GLP-1 receptors, potentially offering better blood sugar control and weight loss compared to current options. This combination could provide a more comprehensive solution for managing both obesity and diabetes.

What evidence suggests that this trial's treatments could be effective for obesity with type 2 diabetes?

Research has shown that both bimagrumab and tirzepatide can aid weight loss in individuals with obesity and type 2 diabetes. This trial will administer different combinations of these treatments to participants. Previous studies found that a combination of these treatments led to a 22.1% body weight reduction over 72 weeks. Participants using bimagrumab alone lost about 20.5% of their body weight and experienced improvements in body composition, such as increased muscle mass. Tirzepatide has also proven effective, resulting in significant weight loss at various doses and enhancing health. These treatments reduce fat and increase muscle, which is crucial for managing obesity and type 2 diabetes. ^{1 2 3 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for individuals with obesity or overweight who also have type 2 diabetes. Participants will be involved in the study for approximately 13 months. Specific eligibility criteria are not provided, but typically include factors like age range, disease severity, and absence of certain medical conditions.

Inclusion Criteria

Have type 2 diabetes

Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)

My BMI is 27 or higher.

Exclusion Criteria

I have had or am planning to have surgery for weight loss.

I have type 1 diabetes or a history of severe diabetic complications.

My high blood pressure is not well-managed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bimagrumab, tirzepatide, or a combination to assess efficacy and safety in lowering body weight

13 months

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 the effectiveness and safety of bimagrumab and tirzepatide, alone or combined, in reducing body weight. It involves comparing these drugs to their placebos over a period to assess improvements in participants' condition.

How Is the Trial Designed?

Group I: Tirzepatide Dose 2 + Bimagrumab Placebo Experimental Treatment 2 Interventions

Participants will receive tirzepatide SC and bimagrumab placebo SC

Group II: Tirzepatide Dose 1 + Bimagrumab Placebo Experimental Treatment 2 Interventions

Participants will receive tirzepatide SC and bimagrumab placebo SC

Group III: Bimagrumab Dose 2 + Tirzepatide Placebo Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide placebo SC

Group IV: Bimagrumab Dose 2 + Tirzepatide Dose 2 Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide SC

Group V: Bimagrumab Dose 2 + Tirzepatide Dose 1 Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide SC

Group VI: Bimagrumab Dose 1 + Tirzepatide Placebo Experimental Treatment 2 Interventions

Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC

Group VII: Bimagrumab Dose 1 + Tirzepatide Dose 2 Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide SC

Group VIII: Bimagrumab Dose 1 + Tirzepatide Dose 1 Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide SC

Group IX: Bimagrumab Placebo + Tirzepatide Placebo Placebo Group 2 Interventions

Participants will receive bimagrumab placebo SC and tirzepatide placebo SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

In a 72-week phase 3 trial involving 938 adults with obesity and type 2 diabetes, tirzepatide (10 mg and 15 mg) led to significant weight loss, with reductions of -12.8% and -14.7% respectively, compared to only -3.2% with placebo.

The safety profile of tirzepatide was generally favorable, with most adverse events being mild to moderate gastrointestinal issues, and serious adverse events were rare, indicating it is a safe option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Garvey, WT., Frias, JP., Jastreboff, AM., et al.[2023]

Tirzepatide significantly improved quality of life (QoL) and treatment satisfaction in patients with type 2 diabetes across five clinical trials, with higher doses leading to greater improvements.

The improvements in QoL were measured using various patient-reported outcomes over 40 to 52 weeks, indicating that tirzepatide is effective not only for glycemic control but also for enhancing overall well-being in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Boye, KS., Thieu, VT., Sapin, H., et al.[2023]

Tirzepatide (Mounjaro™) is a new treatment for type 2 diabetes that acts on both GIP and GLP-1 receptors, showing strong results in lowering blood glucose and promoting weight loss based on evidence from five SURPASS clinical trials.

The safety profile of tirzepatide is similar to that of existing GLP-1 receptor agonists, making it a promising option for early intervention in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Drug: Tirzepatide (Mounjaro&#8482;). Gettman, L.[2023]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2774903

Effect of Bimagrumab vs Placebo on Body Fat Mass Among ... In the current study, patients with type 2 diabetes who had overweight or obesity lost 20.5% of their total body FM, had a 3.6% increase in lean ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33439265/

Effect of Bimagrumab vs Placebo on Body Fat Mass Among ... In this phase 2 randomized clinical trial, ActRII blockade with bimagrumab led to significant loss of FM, gain in LM, and metabolic improvements during 48 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03005288

Study Details | NCT03005288 | Safety, Pharmacokinetics ... Study Overview. Brief Summary. This study assessed the safety, pharmacokinetics and efficacy of bimagrumab when administered in overweight and obese patients ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7807292/

Effect of Bimagrumab vs Placebo on Body Fat Mass Among ... In this phase 2 randomized clinical trial, ActRII blockade with bimagrumab led to significant loss of FM, gain in LM, and metabolic improvements during 48 weeks ...

5. 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 ... The results demonstrated the combination of bimagrumab and semaglutide therapy led to greater reductions in weight, body fat, visceral fat, and ...

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000010417

Long-term safety and tolerability of bimagrumab (BYM338) ... This study provides Class IV evidence that for patients with sIBM, long-term bimagrumab treatment was safe and well tolerated and did not lead to functional ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7749589/

Safety and pharmacokinetics of bimagrumab in healthy ... Bimagrumab was safe and well tolerated and demonstrated similar PK in older and obese adults. A single dose of bimagrumab rapidly increased TMV and LBM and ...