In short
Clinical trials are studying LY3841136 SODIUM, also called eloralintide, in people with obesity or overweight and related health problems. These studies look at whether it helps with body weight and, in some trials, sleep apnea or knee pain from osteoarthritis. Most trials are Phase 3 studies in adults.
Key points
- Clinical trials of LY3841136 SODIUM, also called eloralintide, are studying adults with obesity or overweight. The main goal in most studies is to see whether it lowers body weight more than placebo. Some trials also look at obstructive sleep apnea, type 2 diabetes, or knee pain from osteoarthritis. All listed studies are Phase 3, which means they are testing the treatment in larger groups of people. The trials are authorised and use body weight change as the main outcome in most cases. One study also measures sleep apnea severity, and another measures a pain score for osteoarthritis.
Trial overview
The clinical trials in this article study LY3841136 SODIUM, which is also named eloralintide in the trial titles.
All five listed studies are interventional trials, which means participants are assigned to receive a study treatment or a comparison treatment.
The main research focus is body weight change in people with obesity or overweight, with some studies also looking at sleep apnea or knee pain from osteoarthritis.
Who is being studied
The trials include people with obesity or overweight, which are the main target populations across the studies.
One study includes participants with obstructive sleep apnea and obesity or overweight.
One study includes participants with obesity or overweight and type 2 diabetes.
One study includes participants with osteoarthritis knee pain and obesity or overweight.
One study includes participants with persistent obesity who are treated with a weekly incretin, which is the wording used in the trial title.
Trial goals and endpoints
The main goal in most studies is to show that LY3841136 SODIUM is better than placebo for percent change from baseline in body weight.
In the study of obstructive sleep apnea, the trial also aims to show superiority over placebo for apnea-hypopnea index, which is a measure of how often breathing stops or becomes shallow during sleep.
In the osteoarthritis study, the two main goals are body weight change and change in the WOMAC pain subscale score, which measures knee pain from osteoarthritis.
Several studies measure body weight change at Week 64, showing that the trials are designed to follow results over a long period.
Trial phases and status
All listed studies are in Phase 3, the stage where a treatment is tested in larger groups of people to confirm how well it works.
Each trial is marked Authorised, which means the studies have been approved to move forward in the source data.
The study sizes are fairly large, with enrollment ranging from 254 to 1035 participants.
Study design and comparators
These studies compare LY3841136 SODIUM with a placebo, which is a look-alike treatment used to make the comparison fair.
The trial titles show that LY3841136 SODIUM is given by subcutaneous use, meaning it is given under the skin.
The source data do not provide detailed eligibility rules, so the safest summary is that these studies are for adults with the conditions named in each trial title.
Key trials
ENLIGHTEN-1 studies participants with obesity or overweight without type 2 diabetes and measures percent change from baseline in body weight at Week 64.
ENLIGHTEN-2 studies participants with obesity or overweight and type 2 diabetes, also with body weight change as the main outcome.
ENLIGHTEN-3 studies participants with obstructive sleep apnea and obesity or overweight, and it looks at both body weight and apnea-hypopnea index.
ENLIGHTEN-4 studies participants with osteoarthritis knee pain and obesity or overweight, and it measures body weight plus WOMAC pain score.
ENLIGHTEN-6 studies participants with persistent obesity who are treated with a weekly incretin, and it focuses on body weight change.
Patient-focused terms
Baseline means the starting point before treatment begins.
Percent change from baseline means how much a value changes compared with the starting value, shown as a percent.
Primary outcome means the main result the researchers want to measure in the trial.
Enrollment means the number of participants planned for the study.