Bimagrumab + Tirzepatide for Obesity with Type 2 Diabetes

Recruiting at 35 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.

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 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.

Treatment Details

Interventions

• Bimagrumab (Monoclonal Antibodies)
• Tirzepatide (Other)

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.

Participant Groups

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