Bimagrumab + Semaglutide for Obesity

Recruiting at 63 trial locations

Overseen By Kiran Dole, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must not be taking: Antidiabetics, Investigational drugs

Disqualifiers: Diabetes, Chronic infections, others

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

Compensation: Varies

Number of Visits: 4

Duration: 48 weeks

507 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether bimagrumab alone or with semaglutide can help overweight or obese men and women keep or increase their muscle mass while losing weight. Bimagrumab helps build or maintain muscle, and semaglutide helps reduce appetite and promote weight loss. Bimagrumab is a new agent with a unique way of working.

Do I need to stop my current medications to join the trial?

The trial requires that you stop any medication specifically for obesity at least 30 days before screening. If you are taking medications for other conditions, the protocol does not specify whether you need to stop them, so it's best to discuss this with the trial team.

Is the combination of Bimagrumab and Semaglutide safe for humans?

Semaglutide, used in medications like Wegovy and Rybelsus, has been shown to be generally safe for weight management and type 2 diabetes, with a safety profile similar to other drugs in its class. It has been tested in many patients and found to be safe for the heart in those at high risk for heart problems. ^{1 2 3 4 5}

What makes the drug combination of Bimagrumab and Semaglutide unique for treating obesity?

The combination of Bimagrumab and Semaglutide is unique because Semaglutide, a glucagon-like peptide-1 receptor agonist, has shown significant weight loss results, reducing body weight by about 15% over 68 weeks, which is higher than other obesity medications. This combination could potentially enhance weight loss and improve cardiovascular health, offering a novel approach compared to existing treatments. ^{1 3 6 7 8}

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

Eligibility Criteria

Adults aged 18-80 who are overweight or obese (BMI ≥ 30, or BMI ≥ 27 with related health issues like high blood pressure) can join. They must have tried to lose weight before without success and be willing to follow the study's diet and activity plans. Women able to have children need two negative pregnancy tests and must use an IUD plus a barrier method for contraception.

Inclusion Criteria

A written informed consent must be obtained before any study-related assessments are performed

History of at least one self-reported unsuccessful behavioral effort to lose body weight

Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities

Exclusion Criteria

I am allergic to some specific drug types or cannot take semaglutide.

I do not have chronic infections like HBV, HCV, or HIV.

I haven't taken any obesity medication in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous bimagrumab and subcutaneous semaglutide according to the dose escalation schedule

48 weeks

Visits at baseline, Weeks 4, 16, 28, 40, 52, and 64

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Extension

Participants may continue to receive bimagrumab during the extension period

24 weeks

Treatment Details

Interventions

• Bimagrumab
• Semaglutide

Trial Overview The trial is testing Bimagrumab alone or combined with Semaglutide against a placebo in men and women who are overweight or obese. It aims to find out how effective these treatments are at helping participants lose weight, as well as their safety profiles.

Participant Groups

Group I: Placebo + semaglutide 2.4 mg Experimental Treatment 2 Interventions

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28 and 40, 52 and 64, and s.c. semaglutide 2.4 mg weekly per the dose escalation schedule.

Group II: Placebo + semaglutide 1.0 mg Experimental Treatment 2 Interventions

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Group III: Bimagrumab 30 mg/kg + semaglutide 2.4 mg Experimental Treatment 2 Interventions

Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 2.4 mg per the dose escalation schedule.

Group IV: Bimagrumab 30 mg/kg + semaglutide 1.0 mg Experimental Treatment 2 Interventions

Participants will receive i.v. bimagrumab 30 mg/kg at baseline, and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Group V: Bimagrumab 30 mg/kg + no semaglutide Experimental Treatment 1 Intervention

Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64.

Group VI: Bimagrumab 10 mg/kg to bimagrumab 30 mg/kg + no semaglutide Experimental Treatment 1 Intervention

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28 and 40 during the core treatment period and will switch during the extension period to receive bimagrumab 30 mg/kg at Weeks 52 and 64.

Group VII: Bimagrumab 10 mg/kg + semaglutide 2.4 mg Experimental Treatment 2 Interventions

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 2.4 mg weekly per the dose escalation schedule.

Group VIII: Bimagrumab 10 mg/kg + semaglutide 1.0 mg Experimental Treatment 2 Interventions

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Group IX: Placebo to bimagrumab 30 mg/kg + no semaglutide Placebo Group 2 Interventions

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28 and 40 during the core treatment period and will switch during the extension period to receive bimagrumab 30 mg/kg at Weeks 52 and 64.

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

Versanis Bio, Inc.

Industry Sponsor

Trials

2

Recruited

570+

Findings from Research

Semaglutide, approved by the FDA on June 4, 2021, is the first new drug for chronic weight management in adults with obesity or overweight since 2014, specifically targeting those with a BMI of 27 or greater and at least one weight-related condition.

This medication is intended to be used alongside a weight management program that includes a reduced-calorie diet and increased physical activity, highlighting its role as part of a comprehensive approach to weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. Mares, AC., Chatterjee, S., Mukherjee, D.[2023]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to produce the largest weight loss of any obesity medication, with an average reduction of about 15% of initial body weight over 68 weeks.

In addition to significant weight loss, semaglutide also improves cardiovascular risk factors and physical functioning, making it a promising option for chronic weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

Subcutaneous semaglutide (Wegovy) has been shown to significantly reduce body weight in overweight and obese individuals, with a dose-dependent effect observed in four Phase 3 trials involving 5000 participants.

While semaglutide resulted in greater weight loss compared to placebo, gastrointestinal side effects were the most common safety concerns, highlighting the need for further studies in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review of subcutaneous semaglutide for obesity. Phillips, A., Clements, JN.[2022]

High-dose once-weekly semaglutide has been shown to significantly reduce weight in patients with obesity or overweight, as demonstrated in four phase 3 clinical trials involving various populations, including those with diabetes.

While gastrointestinal side effects were common, semaglutide was generally well tolerated and also led to improvements in cardiometabolic risk factors, such as waist circumference and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2022]

Semaglutide 2.4mg was found to be the most effective treatment for weight loss in people with obesity, resulting in an average loss of 12.47 kg, and also significantly reduced HbA1c levels compared to placebo.

While semaglutide 2.4mg showed the best efficacy, it also had the highest incidence of adverse events, including hypoglycemia, indicating a trade-off between effectiveness and safety compared to liraglutide treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Liraglutide and Semaglutide on Weight Loss in People with Obesity or Overweight: A Systematic Review. Xie, Z., Yang, S., Deng, W., et al.[2022]

Semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, has been shown to achieve significant and sustained weight loss in individuals with obesity, surpassing results from previous weight-loss medications, and has been approved for use alongside diet and exercise.

Emerging treatments like tirzepatide and cagrilintide are demonstrating even greater weight loss effects than semaglutide, indicating a shift towards more effective 'weight-centric' strategies for managing obesity and related conditions like type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? Colin, IM., Gérard, KM.[2022]

Semaglutide, a GLP-1 receptor agonist, has been shown to effectively lower hemoglobin A1c levels by approximately -1.5% and reduce body weight by about -4.5 kg in phase 3 trials, demonstrating comparable efficacy to dulaglutide.

While semaglutide offers cardiovascular benefits, including a reduced risk of major cardiovascular events, it is associated with an increased risk of retinopathy complications in patients with existing diabetic retinopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the Treatment of Type 2 Diabetes Mellitus. Miles, KE., Kerr, JL.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. [2023]

2. Belgium pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Clinical review of subcutaneous semaglutide for obesity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Liraglutide and Semaglutide on Weight Loss in People with Obesity or Overweight: A Systematic Review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for the Treatment of Type 2 Diabetes Mellitus. [2021]