Join Trial Testing New Drug for Weight Management
A clinical trial is recruiting adults with type 2 diabetes to test a new long-lasting amylin drug for weight management.
Trial Status: Recruiting
Clinical Trials Identifier: NCT07282600
Trial Name: A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes (ENLIGHTEN-2)
Diabetes Type: Type 2 diabetes
Trial Sponsor: Eli Lilly and Company
Why is this study important?
This study is testing the safety and efficacy of an experimental drug, eloralintide, for weight management in people with type 2 diabetes and overweight or obesity. Eloralintide works similarly to medications like semaglutide (Ozempic) and tirzepatide (Mounjaro), but it targets receptors for amylin (a hormone that helps regulate blood sugar and appetite) instead of GLP-1 and GIP receptors.
Amylin is produced by beta cells in the pancreas, which store the hormone alongside insulin. When the stomach is full and blood sugar starts to rise, the body sends out GLP-1 and GIP hormones, which tell beta cells to release insulin and amylin. Aside from communicating with the pancreas, GLP-1 and GIP also interact with the stomach to slow digestion and the brain to promote feelings of fullness. Once amylin is in the bloodstream, it causes similar responses in the central nervous system and digestive tract.
Because amylin interacts with a different set of receptors, its effects are different from GLP-1 and GIP. In particular, amylin drugs don’t stimulate the release of insulin during mealtime blood sugar spikes. Their contributions to blood sugar management depend entirely on their ability to slow down the amount of sugar entering the bloodstream.
Eloralintide is not the first amylin drug. Pramlintide (Symlin) has been available to people with type 1 and type 2 diabetes since 2005, the same year exenatide (Byetta), the first GLP-1 drug, went on the market. However, eloralintide is part of a new generation of amylin drugs that, like their next-generation GLP-1 counterparts, were designed to last longer (once weekly) than medicines like Symlin, which must be taken before meals and has side effects like nausea and vomiting.
Cagrilintide, another long-lasting amylin drug, has been submitted to the FDA for approval, but it has been packaged with semaglutide in a weekly injection called CagriSema. So far, all of the research on that drug has focused on its use in combination with semaglutide.
This trial will be the first large, phase 3 trial to test the safety and efficacy of a long-lasting amylin drug taken on its own. The results of a smaller phase 2 trial that included people with overweight or obesity but not type 2 diabetes suggested that eloralintide may cause relatively mild side effects while still producing similar weight loss to semaglutide and tirzepatide.
How does the trial work?
Researchers are aiming to recruit 1,035 people with type 2 diabetes and overweight or obesity. Participants will be randomly assigned to one of five groups. Four of the groups will receive one of four different doses of eloralintide. The fifth will take a placebo.
The researchers are asking participants to commit to a 75-week trial. Their plan is to collect comprehensive health data from each participant, including weight, body mass index (BMI), waist circumference, A1C, blood lipids, blood pressure, and eGRF (a measure of kidney function), at the start of the trial and after 64 weeks of weekly injections.
The researchers have not provided information about whether participants will continue to take weekly injections in the 11 weeks of follow-up. Participants may expect as many as 20 visits over the 75-week trial, but aside from the baseline and 64-week health checks, it’s unclear what will happen at each visit.
Are you interested in participating?
You may be eligible to participate if you are at least 18 years old and:
- Have type 2 diabetes that’s been managed with a stable treatment regimen for at least 90 days
- Have a BMI of at least 27 and a body weight that has been stable for at least 90 days
People who are currently or were recently taking GLP-1, GIP, amylin, or insulin drugs are not eligible to participate. People are also ineligible if they are managing their weight with other medications or surgical procedures, and if they have a history of heart problems. See a full list of inclusion/exclusion criteria here.
Learn more about treatments for type 2 diabetes here: