Eloralintide for Obesity
(ENLIGHTEN-2 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 if it can safely aid weight loss in individuals with overweight or obesity and type 2 diabetes. Participants will receive varying doses of eloralintide or a placebo for comparison. The study seeks individuals with type 2 diabetes who are on stable diabetes treatment and have faced challenges with weight management. Participation will last approximately 75 weeks. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial requires that you have been on stable treatment for type 2 diabetes for at least 90 days before joining. However, you cannot have taken certain diabetes medications like insulin or GLP-1 receptor agonists within 90 days before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that eloralintide was generally well-tolerated in earlier studies. This treatment, which helps control appetite and food intake, led to significant weight loss over 48 weeks. Tested at different doses, it showed good safety results, with few serious side effects reported.
In an earlier study with adults, eloralintide was well-tolerated, meaning most participants did not experience severe or dangerous side effects. While some mild side effects might occur, past research suggests overall safety looks promising.
The current trial, being at a later stage, indicates that earlier results were positive enough to continue. This phase focuses on confirming safety and effectiveness in a larger group.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Eloralintide for obesity because it potentially offers a new way to tackle weight loss. Unlike current treatments that often rely on appetite suppression or altering metabolism with oral medications, Eloralintide is administered through subcutaneous injections. This method might provide more direct and sustained effects on weight management. Eloralintide's mechanism could involve novel pathways or receptors, making it a compelling option for individuals who have not seen success with existing therapies.
What evidence suggests that eloralintide might be an effective treatment for obesity?
Research has shown that eloralintide, a drug being tested for weight loss in this trial, delivers promising results. In earlier studies, individuals with obesity who took eloralintide lost between 9.5% and 20.1% of their weight over 48 weeks. The drug targets a specific receptor in the body that helps control appetite and food intake. These findings suggest that eloralintide could be effective for those seeking weight loss, particularly if they have conditions like type 2 diabetes. Participants in this trial will receive one of several doses of eloralintide or a placebo to further evaluate its effectiveness.12567
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 adults with obesity or overweight who also have type 2 diabetes. Participants should be interested in reducing body weight and must commit to a study duration of about 75 weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive eloralintide or placebo subcutaneously for body weight reduction
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Eloralintide
Trial Overview
The trial is testing the effectiveness and safety of a drug called Eloralintide versus a placebo in helping participants lose weight. The study will compare changes in body weight between the two groups over the course period.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive eloralintide SC
Participants will receive eloralintide SC
Participants will receive eloralintide SC
Participants will receive eloralintide subcutaneously (SC)
Participants will receive placebo 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
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 ...
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 ...
3.
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 ...
At 48 weeks, all treatment arms of eloralintide met the primary endpoint, demonstrating superior mean weight reductions from 9.5% to 20.1% ...
Novel amylin receptor agonist induces 'clinically ...
Eloralintide conferred weight loss of up to 20.1% at 48 weeks for adults with obesity. Adults who began with a 3 mg dose of the drug and ...
5.
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.
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 ...
What to know about eloralintide
Eloralintide is an investigational, once-weekly injectable medication that is being studied for the treatment of obesity. It belongs to a class ...
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