Eloralintide for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and metabolism of two versions of a new drug called eloralintide. Participants will receive the drug via subcutaneous injection, and researchers will monitor the body's reactions over 13 weeks. Eligible participants must be generally healthy, with a body mass index (BMI) between 20.0 and 32.0, and free from diabetes or any serious medical conditions that could affect drug processing. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that eloralintide is usually well-tolerated, but some people experience side effects. In studies, the most common issues included mild to moderate stomach-related symptoms such as nausea, diarrhea, and vomiting. These side effects varied with the dose; higher doses generally caused more discomfort.
For instance, 11% of people taking 1 mg of eloralintide felt nauseous, while 64% of those on a 6 mg dose experienced nausea. Reports also included tiredness and mild reactions at the injection site. Serious side effects were rare, indicating that eloralintide is fairly safe for most people. However, individual experiences with the treatment can vary.12345Why are researchers excited about this trial's treatments?
Eloralintide is unique because it is a peptide-based treatment being tested for its potential benefits in healthy volunteers. Unlike traditional treatments that may involve oral medications or intravenous delivery, Eloralintide is administered subcutaneously, directly under the skin, which can offer a more targeted and efficient delivery method. Researchers are excited about this treatment's potential due to its novel formulation, which might offer improved absorption and efficacy compared to existing options. Additionally, the development of both a reference and test formulation allows for a comprehensive understanding of its performance and potential advantages.
What evidence suggests that this trial's treatments could be effective?
Research has shown that eloralintide may aid in weight loss. One study found that participants lost between 9% and 20% of their body weight over 48 weeks, depending on the dose received. In contrast, those on a placebo (a treatment with no active ingredient) lost only 0.4% of their weight. Eloralintide targets a specific receptor that controls appetite and food intake, potentially helping individuals eat less and lose weight effectively. In this trial, participants will receive either the eloralintide reference formulation or the test formulation to evaluate its effects.15678
Who Is on the Research Team?
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Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for healthy adults who do not have any significant medical conditions. Participants should generally be in good health and able to complete all study visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Inpatient Treatment
Participants receive single doses of two different eloralintide solutions administered subcutaneously
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Eloralintide
Trial Overview
The study is testing the safety and how the body processes two different forms of a new drug called eloralintide. All participants will receive the drug, and the study lasts about 13 weeks with screening, treatment, and follow-up.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive eloralintide test formulation administered SC.
Participants will receive eloralintide reference formulation administered subcutaneously (SC).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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
Citations
1.
appliedclinicaltrialsonline.com
appliedclinicaltrialsonline.com/view/eli-lilly-trial-eloralintide-weight-reduction-adults-obesityEli 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 (LY3841136), a novel amylin receptor agonist for ...
Eloralintide demonstrated favorable pharmacokinetics in both rats and monkeys. In the phase 1 trial, 48 healthy participants had a mean body mass index of 27.5 ...
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% ...
Eloralintide, a selective amylin receptor agonist for the ...
The primary endpoint was percent change in bodyweight from baseline after 48 weeks of treatment. Efficacy analyses included all randomly ...
6.
lilly.gcs-web.com
lilly.gcs-web.com/news-releases/news-release-details/lillys-selective-amylin-agonist-eloralintide-demonstratedLilly's selective amylin agonist, eloralintide, demonstrated ...
The most common adverse events were mild to moderate gastrointestinal symptoms and fatigue, which were seen more frequently in the higher dose ...
Eloralintide: A selective alternative targeting the amylin ...
gastrointestinal adverse events, fatigue and heart rate reduction as the most notable adverse events.
Eloralintide, a selective, long‐acting amylin receptor agonist ...
Gastrointestinal adverse events, including diarrhoea (10% of participants), nausea (8%), and vomiting (4%), were infrequent in those receiving ...
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