400 Participants NeededMy employer runs this trial

Macupatide + Eloralintide for Obesity

Recruiting at 40 trial locations
Tq
Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
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 tests two treatments, macupatide and eloralintide, to determine their safety and effectiveness in helping people with obesity or overweight lose weight. Participants will receive various combinations of these treatments or a placebo to compare effects. The trial aims to assess the treatments' effectiveness in individuals without type 2 diabetes. Suitable candidates include those who have struggled with obesity and do not have type 2 diabetes or a history of certain heart conditions. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that any medications you are currently taking should be at a stable dose for at least 3 months before you start the trial.

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

Previous studies have tested both macupatide and eloralintide for safety in humans. Research shows that eloralintide is generally well-tolerated. Specifically, after 48 weeks, it resulted in significant weight loss without major safety concerns, as noted in source 5. Most participants experienced only mild to moderate side effects.

Macupatide has also undergone safety evaluation and is being studied for its potential to aid weight loss in people with obesity. Although detailed safety information for macupatide alone is less clear, testing with eloralintide suggests a reasonable safety profile.

Since this trial is in Phase 2, earlier testing demonstrated that the treatments were safe enough to proceed. However, more information is needed to fully understand any potential risks. Participants might experience some side effects, but these are usually not severe.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Macupatide and Eloralintide for obesity because they offer a fresh approach compared to current options like diet, exercise, and medications such as orlistat, liraglutide, or phentermine. Unlike these standard treatments, Macupatide and Eloralintide are designed to be administered subcutaneously (under the skin), which may offer more consistent therapeutic effects. The combination of these two drugs targets multiple pathways involved in weight regulation, potentially making them more effective at promoting weight loss and maintaining it. Additionally, these treatments may have a unique mechanism of action that could offer benefits beyond just weight loss, such as improving metabolic health.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that macupatide and eloralintide hold promise for weight loss. In studies, participants using these treatments lost between 9.5% and 20.1% of their body weight over 48 weeks. This trial may administer either macupatide or eloralintide alone, or a combination of both. Eloralintide targets a hormone that helps control weight, and higher doses resulted in greater weight loss. When combined with eloralintide, macupatide also contributes to significant weight reduction. These findings suggest both treatments could effectively aid weight loss in individuals with obesity.34567

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 who are overweight or have obesity but do not have type 2 diabetes. Participants should be generally healthy aside from their weight and meet other criteria set by the main study protocol.

Inclusion Criteria

I meet the main study's inclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive macupatide and/or eloralintide or placebo subcutaneously for weight management

60 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eloralintide
  • Macupatide

Trial Overview

The study tests two new medications, macupatide and eloralintide, given alone or together, compared to a placebo (inactive treatment), to see how well they help with weight loss over about 64 weeks.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Placebo Group

Group I: Macupatide Dose 2 + Eloralintide Dose 3Experimental Treatment2 Interventions
Group II: Macupatide Dose 1 + Eloralintide Dose 2Experimental Treatment2 Interventions
Group III: Macupatide Dose 1 + Eloralintide Dose 1Experimental Treatment2 Interventions
Group IV: Macupatide Dose 1Experimental Treatment1 Intervention
Group V: Eloralintide Dose 3Experimental Treatment1 Intervention
Group VI: Eloralintide Dose 2Experimental Treatment1 Intervention
Group VII: Eloralintide Dose 1Experimental Treatment1 Intervention
Group VIII: PlaceboPlacebo Group1 Intervention

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

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41207310/

Eloralintide, a selective amylin receptor agonist for the ...

Interpretation: Eloralintide produced clinically meaningful, dose-dependent reductions in bodyweight over 48 weeks and was generally well ...

Lilly's selective amylin agonist, eloralintide, demonstrated ...

At 48 weeks, all treatment arms of eloralintide met the primary endpoint, demonstrating superior mean weight reductions from 9.5% to 20.1% ...

NCT07282600 | A Study of Eloralintide (LY3841136) in ...

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with ...

Eloralintide, a selective amylin receptor agonist for the ...

Eloralintide produced clinically meaningful, dose-dependent reductions in bodyweight over 48 weeks and was generally well tolerated, supporting ...

Eli Lilly's Phase II Trial of Eloralintide Shows Up to 20 ...

Mean weight loss ranged from 9% at the lowest dose to 20% at 9 mg after 48 weeks. Placebo group saw a 0.4% mean reduction in body weight.

Eloralintide, a selective, long‐acting amylin receptor agonist ...

Long‐term safety of eloralintide is unknown; however, pramlintide has been used clinically for ~15 years, providing some confidence in the ...

Eloralintide (LY3841136), a novel amylin receptor agonist ...

In the clinical trial, descriptive statistics were used to summarize demographic data, adverse events, and safety data. Plasma concentrations of ...