56 Participants NeededMy employer runs this trial

Eloralintide for Obesity

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company

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 effect on the rate of stomach emptying in individuals who are overweight or obese. Researchers aim to discover if Eloralintide can aid weight management by slowing digestion. Participants will be divided into groups, with some receiving Eloralintide and others a placebo (a harmless, inactive substance). This trial may suit those who have been overweight or obese for a while and whose weight has remained stable over the past three months. As a Phase 1 trial, participants will be among the first to receive this new treatment, assisting researchers in understanding its effects on people.

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

Earlier studies found that Eloralintide was generally well tolerated. Research has shown that no deaths occurred during the trials, and only a small number of participants experienced serious side effects. The most common side effect was decreased appetite, affecting more than 10% of those taking Eloralintide. Other studies have found that most people did not experience severe or dangerous side effects. This suggests that Eloralintide is quite safe for humans.12345

Why do researchers think this study treatment might be promising for obesity?

Unlike most current obesity treatments that focus primarily on appetite suppression or calorie absorption, Eloralintide offers a unique approach by targeting metabolic pathways to enhance energy expenditure. Researchers are excited about Eloralintide because it is administered subcutaneously (SC), which can offer more consistent dosing and potentially fewer side effects compared to oral medications. Additionally, its novel mechanism may provide a new avenue for managing obesity, offering hope for those who haven't found success with existing therapies.

What evidence suggests that Eloralintide might be an effective treatment for obesity?

Studies have shown that Eloralintide, a drug targeting the amylin receptor, can significantly aid weight loss in overweight or obese individuals. Research indicates that after 48 weeks, patients lost between 9% and 20% of their weight, depending on the dose. Specifically, a 9 mg dose resulted in the highest average weight loss of 20%. This trial will include various cohorts receiving different doses of Eloralintide, along with a placebo group, which in previous studies resulted in only a 0.4% weight loss. These findings suggest that Eloralintide could be an effective option for weight management.46789

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 people who are overweight or obese. Participants should be generally healthy aside from their weight and able to attend multiple clinic visits over about 21 weeks.

Inclusion Criteria

Have had a stable body weight, with less than 5 percent (%) change during the 3-month period prior to screening
Have overweight or obesity, but are otherwise overtly healthy
Have a body mass index (BMI) within the range of 27.0 to 45.0 kilograms (kg)/square meter (m²), inclusive

Exclusion Criteria

Have Hemoglobin A1C (HbA1c) greater than or equal to 6.5% or 48 mmol/mole (mol) at screening
I have been diagnosed with diabetes.
Have a fasting plasma glucose concentration greater than or equal to 126 milligrams (mg)/deciliter (dL) or 7.0 millimoles (mmol)/liter (L) at screening
See 3 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 administered subcutaneously to evaluate gastric emptying delay, pharmacokinetics, safety, and tolerability

21 weeks
2 overnight stays (4-8 days each), 13 other visits

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 is testing a new drug called Eloralintide to see if it slows down how quickly the stomach empties in people with excess weight. Some participants will get Eloralintide, while others will receive a placebo or acetaminophen for comparison.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Placebo Group

Group I: Eloralintide Cohort 4Experimental Treatment2 Interventions
Group II: Eloralintide Cohort 3Experimental Treatment2 Interventions
Group III: Eloralintide Cohort 2Experimental Treatment2 Interventions
Group IV: Eloralintide Cohort 1Experimental Treatment2 Interventions
Group V: 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

Citations

1.

pubmed.ncbi.nlm.nih.gov

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

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 ...

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% ...

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.

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 alternative targeting the amylin ...

eloralintide producing significant, dose-dependent weight loss within 48 weeks: an average reduction of 9% (1 mg), 12% (3 mg), 18% (6 mg), and 20% (9 mg), ...

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 ...

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

No deaths were reported during the study. Adverse events occurring in ≥10% of participants receiving eloralintide included decreased appetite ( ...

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

In a phase 3 trial in people with overweight or obesity, once-weekly cagrilintide (2.4 mg) monotherapy over 68 weeks reduced mean body weight from baseline by ...

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.