Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 64 weeks

LY3841136 + Tirzepatide for Obesity with Type 2 Diabetes

Not currently recruiting at 57 trial locations

Overseen ByJeffrey A Norton

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must be taking: Metformin, SGLT2 inhibitors

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

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?

This trial explores whether the drug LY3841136, alone or combined with Tirzepatide (a medication for weight management), can aid long-term weight management in individuals with Type 2 Diabetes. Researchers aim to assess the safety and effectiveness of these treatments across various doses. The trial spans approximately 64 weeks and seeks participants with Type 2 Diabetes who have faced weight issues for at least three months and manage their diabetes with diet, exercise, or specific medications. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to early findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Tirzepatide is generally well-tolerated. The FDA approved it for treating type 2 diabetes in May 2022. Safety data from several studies indicate it is safe, with some people experiencing mild side effects.

Earlier studies on LY3841136 have focused on its use for weight management. Although detailed safety data is limited, its testing with Tirzepatide in a Phase 2 trial suggests promise in earlier research.

Ongoing studies are examining the combination of LY3841136 and Tirzepatide to assess tolerance. While specific safety data for this combination is not detailed, the progression to this trial phase suggests earlier findings were positive enough to continue. Participants may experience some side effects, but these are typically mild, as seen in related treatments.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about LY3841136 and Tirzepatide for treating obesity in people with Type 2 Diabetes because they promise a fresh approach to managing these conditions. Unlike traditional treatments that often focus on either blood sugar control or weight loss separately, this combination targets both issues simultaneously. LY3841136 is a new active ingredient that, when paired with Tirzepatide, a known GLP-1 receptor agonist, could enhance weight loss and improve metabolic health more effectively. This dual-action strategy has the potential to provide better outcomes than current standard medications, which usually address these problems individually.

What evidence suggests that this trial's treatments could be effective for obesity with Type 2 Diabetes?

Research has shown that LY3841136, also known as eloralintide, yields promising results for weight loss in people with obesity. In earlier studies, participants lost between 9% and 20% of their body weight over 48 weeks. In this trial, some participants will receive LY3841136 alone, while others will receive it combined with tirzepatide. Past trials have demonstrated tirzepatide's effectiveness by targeting specific receptors in the body, leading to significant weight loss. When used together in this trial, these treatments might help people with Type 2 Diabetes manage their weight even more effectively.¹ ³ ⁵ ⁶ ⁷

Who Is on the 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

Are You a Good Fit for This Trial?

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

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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

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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

LY3841136
Tirzepatide

Trial Overview

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

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: LY3841136 Dose 3 + Tirzepatide Dose 3Experimental Treatment2 Interventions