Bimagrumab + Tirzepatide for Obesity

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eli Lilly and Company

Must not be taking: Metformin, Glucose-lowering

Disqualifiers: Diabetes, Hypertension, Heart failure, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.

Will I have to stop taking my current medications?

The trial requires that you do not take metformin or any other glucose-lowering medications. Additionally, you should not be taking medications that may cause significant weight gain or promote weight loss within 3 months before the trial.

What data supports the effectiveness of the drug Bimagrumab + Tirzepatide for obesity?

Research shows that tirzepatide, part of the drug combination, is effective for weight loss in people with obesity, especially those with type 2 diabetes. It works by targeting specific hormones that help control appetite and blood sugar levels. ^{1 2 3 4 5}

Is the combination of Bimagrumab and Tirzepatide safe for humans?

Tirzepatide, also known as LY3298176, has been studied for its safety in treating type 2 diabetes and obesity. It is generally considered safe, but like any medication, it may have side effects. Always consult with a healthcare provider for personalized advice. ^{1 2 5 6 7}

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

Bimagrumab and Tirzepatide together offer a novel approach to treating obesity by combining a muscle-targeting drug (Bimagrumab) with a medication that mimics hormones involved in blood sugar control and appetite regulation (Tirzepatide). This combination may provide a unique benefit by addressing both muscle mass and metabolic factors, unlike other treatments that typically focus on just one aspect. ^{8 9 10 11 12}

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

This trial is for adults with obesity or overweight who also have at least one weight-related health issue but do not have Type 2 Diabetes. The study will last approximately 54 weeks.

Inclusion Criteria

My BMI is over 27 and I have a weight-related health issue.

My weight has been stable, with less than a 5% change, for the last 3 months.

Exclusion Criteria

At least one laboratory value suggestive of diabetes during screening

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

I am taking metformin or other medications to lower my blood sugar.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Bimagrumab and/or Tirzepatide, or placebo, subcutaneously for weight management

54 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bimagrumab (Monoclonal Antibodies)
• Tirzepatide (Other)

Trial Overview The effectiveness and safety of two medications, Bimagrumab and Tirzepatide, are being tested. They can be given alone or together to see how well they help with weight management in obese or overweight individuals.

Participant Groups

Group I: Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1 Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide SC

Group II: Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1 Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide SC

Group III: Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1 Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide SC

Group IV: Part B: Bimagrumab Dose 1 + Tirzepatide Placebo Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide placebo SC

Group V: Part A: Bimagrumab Dose 2 + Tirzepatide Placebo Experimental Treatment 2 Interventions

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

Group VI: Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2 Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide SC

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

Participants will receive bimagrumab SC and tirzepatide SC

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

Participants will receive bimagrumab SC and tirzepatide SC

Group IX: Part A: Bimagrumab Placebo + Tirzepatide Dose 1 Active Control 2 Interventions

Participants will receive bimagrumab placebo SC and tirzepatide SC

Group X: Part A: Bimagrumab Placebo + Tirzepatide Dose 2 Active Control 2 Interventions

Participants will receive bimagrumab placebo SC and tirzepatide SC

Group XI: Part A: Bimagrumab Placebo + Tirzepatide Placebo Placebo Group 2 Interventions

Participants will receive bimagrumab placebo SC and tirzepatide placebo SC

Group XII: Part B: 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

Findings from Research

In a systematic review of randomized controlled trials involving 5800 patients, tirzepatide was found to be highly effective for weight loss, with 78.22% achieving at least 5% weight loss and 32.28% achieving at least 15% weight loss.

Tirzepatide demonstrated superior weight loss compared to placebo and semaglutide, with a significant mean weight loss of -12.47 kg at the 5 mg dose, while showing a manageable safety profile with only a slight increase in gastrointestinal adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. Tan, B., Pan, XH., Chew, HSJ., et al.[2023]

Liraglutide and semaglutide, GLP-1 receptor mimetics, have been approved for weight management in obese individuals, showing promising results in Phase III clinical trials.

Tirzepatide, a GLP-1R and GIPR co-agonist, has received Fast Track designation for obesity management and may offer fewer side effects, suggesting it could be a more sustainable option for long-term weight management compared to existing GLP-1R mimetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLP-1/GIP analogs: potential impact in the landscape of obesity pharmacotherapy. Lafferty, RA., Flatt, PR., Irwin, N.[2023]

The combination of vibostolimab and pembrolizumab is well tolerated by patients, indicating a favorable safety profile for this treatment regimen.

This combination therapy demonstrates antitumor activity, suggesting it may be an effective option for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Anti-TIGIT Antibody with a PD-1 Inhibitor Shows Promise in Solid Tumors. [2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. [2023]

3. England 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. [2023]

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

Dual GIP and GLP-1 Receptor Agonist Tirzepatide Improves Beta-cell Function and Insulin Sensitivity in Type 2 Diabetes. [2022]

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

SURMOUNTing body weight barriers in type 2 diabetes. [2023]

6. England pubmed.ncbi.nlm.nih.gov

GLP-1/GIP analogs: potential impact in the landscape of obesity pharmacotherapy. [2023]

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

Tirzepatide: Clinical review of the "twincretin" injectable. [2023]

8. England pubmed.ncbi.nlm.nih.gov

AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. [2023]

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

Tiragolumab Impresses in Multiple Trials. [2021]

10. Greece pubmed.ncbi.nlm.nih.gov

Concurrent Nivolumab and Metformin in Diabetic Cancer Patients: Is It Safe and More Active? [2022]

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

Mogamulizumab in Combination with Nivolumab in a Phase I/II Study of Patients with Locally Advanced or Metastatic Solid Tumors. [2023]

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

An Anti-TIGIT Antibody with a PD-1 Inhibitor Shows Promise in Solid Tumors. [2022]