Eloralintide for Obesity and Type 2 Diabetes

(ENLIGHTEN-10 Trial)

Not yet recruiting at 307 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
Must be taking: Antihyperglycemic therapies
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 a new treatment called eloralintide to determine its effectiveness for people with obesity and type 2 diabetes who are at risk for heart problems. The goal is to assess whether it works better than a placebo and is safe to use. Suitable candidates for this trial have type 2 diabetes, a history of unsuccessful diets, and are on stable diabetes medication. Participants should also have a BMI of 25 or higher and be concerned about heart health risks. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking therapy.

Is there any evidence suggesting that eloralintide is likely to be safe for humans?

Research has shown that eloralintide appears safe based on earlier studies. In one study, participants generally handled the treatment well, with no serious side effects reported. Eloralintide helps control appetite and food intake, making it a candidate for weight management in people with obesity and type 2 diabetes. Another study found that most participants had no trouble taking eloralintide. These findings suggest that eloralintide might be safe for humans, but ongoing studies will help confirm this.12345

Why do researchers think this study treatment might be promising?

Eloralintide is unique because it offers a novel approach to managing obesity and type 2 diabetes by being administered subcutaneously, which may enhance patient compliance compared to oral medications. Unlike standard treatments like metformin or GLP-1 receptor agonists, Eloralintide might offer different metabolic benefits, potentially leading to improved weight loss and blood sugar control. Researchers are excited about Eloralintide because it could provide a new mechanism of action, offering hope to those who haven't achieved desired results with current medications.

What evidence suggests that eloralintide might be an effective treatment for obesity and type 2 diabetes?

Research has shown that eloralintide, which participants in this trial may receive, holds promise for individuals with obesity and type 2 diabetes. In earlier studies, participants taking eloralintide lost up to 20.9% of their body weight. It also reduced A1C levels, a measure of blood sugar control, by 2.2%. These findings suggest that eloralintide could aid in weight management and improve blood sugar levels for those with type 2 diabetes.678910

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 obese, have type 2 diabetes, and are at higher risk for heart problems. People with these conditions may be eligible to join.

Inclusion Criteria

Have a HbA1c value between ≥ 6.5% and ≤ 9.5% at screening
Have an increased risk of cardiovascular events
Have a BMI ≥ 25.0 kg/m2 at screening
See 4 more

Exclusion Criteria

I have severe heart failure that limits my physical activity.
I have had or plan to have surgery for obesity.
I have had an artery revascularization procedure in the last 60 days.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eloralintide or placebo subcutaneously once weekly

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eloralintide

Trial Overview

The study compares a new drug called eloralintide to a placebo (inactive treatment) to see if it helps people lose weight and manage their diabetes while monitoring safety. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: EloralintideExperimental Treatment1 Intervention
Group II: 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

Investigative Amylin Agonist Eloralintide Proves Superiority ...

Retatrutide lowered A1C 2.2% vs 1.8% and cut weight 19.5%-20.9% vs 9.4% with semaglutide 2 mg at 80 weeks in adults with type 2 diabetes. Read ...

Eloralintide + Tirzepatide for Obesity · Info for Participants

Tirzepatide, a dual receptor agonist for type 2 diabetes, significantly reduces body weight compared to placebo, with an average weight loss of up to 11.8 kg ...

A Study of Eloralintide (LY3841136) in Participants With ...

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

A study to evaluate the efficacy and safety of eloralintide ...

It is being studied to see how well it helps adults who are overweight, have obesity, or have type 2 diabetes to lose body weight. LY3841136 ...

A Study of Eloralintide (LY3841136) and ... - Lilly Trials

The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in ...

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

Here, we present the results of a Phase 1b multiple‐ascending dose trial exploring the safety and tolerability of repeated doses of eloralintide ...

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

"These Phase 2 data suggest eloralintide could offer a promising tolerability profile without compromising on efficacy, underscoring the ...

A Study of Eloralintide (LY3841136) in Participants With ...

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes.

NCT07392190 | A Study of Eloralintide (LY3841136) in ...

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or ...

A Study of Eloralintide (LY3841136) in Participants With ...

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 ...