Bimagrumab + Tirzepatide for Obesity with Type 2 Diabetes

Recruiting at 47 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

180 Participants Needed

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.

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.

What makes the drug combination of Bimagrumab and Tirzepatide unique for treating obesity with type 2 diabetes?

The combination of Bimagrumab and Tirzepatide is unique because Tirzepatide is a novel drug that acts on two receptors to improve blood sugar control and promote weight loss, while Bimagrumab is known for its potential to increase muscle mass, which could offer a comprehensive approach to managing obesity and type 2 diabetes. ^{1 2 3 4 5}

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.

Timeline

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

Treatment Details

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.

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

Findings from Research

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]

References

1. 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]

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

Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. [2023]

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

Achieving Normoglycemia With Tirzepatide: Analysis of SURPASS 1-4 Trials. [2023]

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

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

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

Effects of Tirzepatide, a Dual GIP and GLP-1 RA, on Lipid and Metabolite Profiles in Subjects With Type 2 Diabetes. [2022]