180 Participants Needed

Bimagrumab + Tirzepatide for Obesity with Type 2 Diabetes

Recruiting at 48 trial locations
MB
DT
GU
Tm
BK
Overseen ByBonnie Kimmel
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

C1

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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.
See 10 more

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?
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Tirzepatide Dose 2 + Bimagrumab PlaceboExperimental Treatment2 Interventions
Group II: Tirzepatide Dose 1 + Bimagrumab PlaceboExperimental Treatment2 Interventions
Group III: Bimagrumab Dose 2 + Tirzepatide PlaceboExperimental Treatment2 Interventions
Group IV: Bimagrumab Dose 2 + Tirzepatide Dose 2Experimental Treatment2 Interventions
Group V: Bimagrumab Dose 2 + Tirzepatide Dose 1Experimental Treatment2 Interventions
Group VI: Bimagrumab Dose 1 + Tirzepatide PlaceboExperimental Treatment2 Interventions
Group VII: Bimagrumab Dose 1 + Tirzepatide Dose 2Experimental Treatment2 Interventions
Group VIII: Bimagrumab Dose 1 + Tirzepatide Dose 1Experimental Treatment2 Interventions
Group IX: Bimagrumab Placebo + Tirzepatide PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

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

Citations

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]
Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. [2023]
Achieving Normoglycemia With Tirzepatide: Analysis of SURPASS 1-4 Trials. [2023]
New Drug: Tirzepatide (Mounjaro&#8482;). [2023]
Effects of Tirzepatide, a Dual GIP and GLP-1 RA, on Lipid and Metabolite Profiles in Subjects With Type 2 Diabetes. [2022]
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