LY3841136 + Tirzepatide for Obesity with Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

+52 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eli Lilly and Company

Must be taking: Metformin, SGLT2 inhibitors

Disqualifiers: Severe hypoglycemia, Cardiovascular conditions, Renal impairment, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.

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

The trial protocol does not specify if you need to stop your current medications. However, it requires that any medications you are taking be at a stable dose for at least 3 months before screening.

What data supports the idea that LY3841136 + Tirzepatide for Obesity with Type 2 Diabetes is an effective drug?

The available research shows that tirzepatide, a component of the treatment, is effective for weight loss in people with obesity and type 2 diabetes. Studies indicate that tirzepatide leads to significant weight loss compared to other treatments. It also improves other health factors like blood pressure and insulin sensitivity. This suggests that LY3841136 + Tirzepatide is an effective option for managing obesity in people with type 2 diabetes. ^{1 2 3 4 5}

What safety data is available for the treatment LY3841136 + Tirzepatide for obesity with type 2 diabetes?

Tirzepatide, also known as Mounjaro, is a dual GIP and GLP-1 receptor agonist approved by the FDA in May 2022 for type 2 diabetes. Safety data from the SURPASS clinical trials indicate that tirzepatide has adverse effects comparable to other GLP-1 receptor agonists. These trials demonstrated its efficacy in glucose lowering and weight loss. The safety profile includes common side effects associated with GLP-1 therapies, such as gastrointestinal issues, but overall, it is considered safe for use in managing type 2 diabetes. ^{2 5 6 7 8}

Is the drug tirzepatide a promising treatment for obesity in people with type 2 diabetes?

Yes, tirzepatide is a promising drug for treating obesity in people with type 2 diabetes. It helps with significant weight loss and improves blood sugar control. It also has positive effects on heart health, like reducing blood pressure and improving cholesterol levels. ^{1 4 6 9 10}

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 Type 2 Diabetes. Participants will be involved in the study for about 64 weeks to test weight management treatments.

Inclusion Criteria

W8M-MC-LAA2: Have a Body Mass Index (BMI) of ≥27 kilograms per square meter (kg/m²)

W8M-MC-LAA2: Have Type 2 Diabetes

W8M-MC-LAA2: Have a HbA1c ≥7.0 % (53 millimoles/mole (mmol/mol)) to ≤10.5% (91 mmol/mol) and treated with diet and exercise alone or with a stable dose of metformin (and not more than the locally approved dose) with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor for at least 3 months prior to screening

Exclusion Criteria

I have a history of pancreatitis.

W8M-MC-LAA2: Have fasting triglycerides >500 milligrams per deciliter (mg/dL) (5.7 mmol/L) at screening

W8M-MC-CWMM: Have a lifetime history of suicide attempts

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3841136 and/or Tirzepatide, or placebo, for weight management

64 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY3841136 (Other)
• Tirzepatide (Other)

Trial Overview The study tests LY3841136 and Tirzepatide, alone or combined, for managing weight. Some participants may receive a placebo instead to compare effects.

Participant Groups

Group I: LY3841136 Dose 3 + Tirzepatide Dose 3 Experimental Treatment 2 Interventions

Participants will receive LY3841136 SC and Tirzepatide SC

Group II: LY3841136 Dose 3 Experimental Treatment 1 Intervention

Participants will receive LY3841136 SC

Group III: LY3841136 Dose 2 + Tirzepatide Dose 3 Experimental Treatment 2 Interventions

Participants will receive LY3841136 SC and Tirzepatide SC

Group IV: LY3841136 Dose 2 + Tirzepatide Dose 2 Experimental Treatment 2 Interventions

Participants will receive LY3841136 SC and Tirzepatide SC

Group V: LY3841136 Dose 2 + Tirzepatide Dose 1 Experimental Treatment 2 Interventions

Participants will receive LY3841136 SC and Tirzepatide SC

Group VI: LY3841136 Dose 2 Experimental Treatment 1 Intervention

Participants will receive LY3841136 SC

Group VII: LY3841136 Dose 1 + Tirzepatide Dose 1 Experimental Treatment 2 Interventions

Participants will receive LY3841136 SC and Tirzepatide SC

Group VIII: LY3841136 Dose 1 Experimental Treatment 1 Intervention

Participants will receive LY3841136 subcutaneously (SC)

Group IX: Tirzepatide Dose 3 Active Control 1 Intervention

Participants will receive Tirzepatide SC

Group X: Placebo Placebo Group 1 Intervention

Participants will receive placebo administered 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

Tirzepatide significantly reduces body weight in patients with type 2 diabetes and obesity, with an average weight loss of -9.81 kg compared to placebo, based on a meta-analysis of 10 studies involving 9,873 patients.

While tirzepatide is effective for weight loss, it has a higher incidence of gastrointestinal side effects compared to placebo, although serious adverse events and hypoglycemia are less common, indicating a need for monitoring these reactions during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss efficiency and safety of tirzepatide: A Systematic review. Lin, F., Yu, B., Ling, B., et al.[2023]

Tirzepatide, a medication for type 2 diabetes, shows a dose-dependent increase in gastrointestinal adverse events (AEs), with nausea and diarrhea being the most common, affecting up to 49% of participants at the highest dose (15 mg).

Despite the gastrointestinal side effects, serious adverse events like severe hypoglycemia and acute pancreatitis are rare (≤ 1%), indicating that tirzepatide is generally safe for use in patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Tirzepatide. Mishra, R., Raj, R., Elshimy, G., et al.[2023]

Tirzepatide, a once-weekly medication for type 2 diabetes, not only improves blood sugar control but also leads to significant weight loss and positive changes in cardiovascular health, such as reduced blood pressure and improved insulin sensitivity.

The weight loss and metabolic benefits of tirzepatide are linked to its dual action as a GIP and GLP-1 receptor agonist, suggesting that these mechanisms play a crucial role in its effectiveness for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. Várkonyi, TT., Pósa, A., Pávó, N., et al.[2023]

Tirzepatide is a novel medication that acts on both GIP and GLP-1 receptors, enhancing insulin secretion and reducing glucagon levels, which helps improve glycemic control in adults with type 2 diabetes mellitus (T2DM).

It received its first approval in the USA in May 2022 for T2DM treatment and is currently being studied for additional conditions like obesity, heart failure, and non-alcoholic steatohepatitis, indicating its potential for broader therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: First Approval. Syed, YY.[2022]

Tirzepatide, a dual GLP-1/GIP receptor co-agonist, has been shown to significantly reduce glycosylated hemoglobin levels (1.87% to 3.02%) and body weight (5.4 to 12.9 kg) in people with type 2 diabetes over treatment periods of up to 104 weeks, demonstrating its efficacy compared to placebo and other diabetes medications.

In individuals without diabetes, tirzepatide also led to substantial weight loss (16.5% to 22.4%) over 72 weeks, indicating its potential for obesity management as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management. Sinha, R., Papamargaritis, D., Sargeant, JA., et al.[2023]

References

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

Weight loss efficiency and safety of tirzepatide: A Systematic review. [2023]

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

Adverse Events Related to Tirzepatide. [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. Ireland pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. [2023]

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

Tirzepatide: First Approval. [2022]

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

New Drug: Tirzepatide (Mounjaro™). [2023]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Tirzepatide: A New Generation Therapeutic for Diabetes Type 2. [2023]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management. [2023]