Macupatide + Eloralintide for Obesity

Recruiting at 38 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must be taking: Metformin, SGLT2 inhibitors

Must not be taking: Amylin RA, GLP-1 RA

Disqualifiers: Type 1 diabetes, Cardiovascular conditions, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments, macupatide and eloralintide, to determine their effectiveness in promoting weight loss in individuals with obesity and type 2 diabetes. Researchers test each treatment alone and in combination to identify the most effective approach. The trial targets adults with type 2 diabetes who have a stable weight, a BMI of 27 or higher, and no recent major weight changes or use of certain diabetes medications. Participants will be involved for approximately 48 weeks. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in diabetes and obesity treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must have been on a stable dose of metformin or an SGLT2 inhibitor for at least 3 months before joining. Some medications, like certain receptor agonists and antihyperglycemic drugs, should not have been used recently.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both macupatide and eloralintide have undergone safety studies in humans. For eloralintide, studies indicate it is generally well-tolerated and aids in weight loss. Participants lost between 9.5% and 20.1% of their weight over 48 weeks, with few serious side effects reported.

Macupatide has also been studied for weight loss. Although detailed safety information for macupatide is limited, its inclusion in multiple studies suggests it is considered safe enough for further research.

Both drugs are being tested, either alone or together, in ongoing studies for obesity and type 2 diabetes. Reaching this phase in clinical trials indicates they have demonstrated a certain level of safety in earlier research. However, discussing potential risks and benefits with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments Macupatide and Eloralintide for obesity because they offer new approaches compared to traditional options like lifestyle changes, medications, or surgery. Macupatide acts on specific pathways in the body that regulate hunger and metabolism, potentially helping patients manage their weight more effectively. Eloralintide, on the other hand, targets different mechanisms that control appetite and energy balance, offering a complementary approach. Together, these treatments could provide a powerful combination that addresses obesity from multiple angles, which is why there's a lot of interest in their potential.

What evidence suggests that this trial's treatments could be effective for obesity?

Studies have shown that eloralintide, a drug targeting specific receptors in the body, leads to significant weight loss in people with obesity. After 48 weeks, participants lost between 9.5% and 20.1% of their body weight, depending on the dose. In this trial, some participants will receive eloralintide alone, while others will receive macupatide alone, which is also under investigation. Researchers are also exploring the combination of macupatide and eloralintide, which might offer additional benefits. These treatments could provide promising options for effective weight loss. ^{2 3 4 6 7}

Who Is on the Research Team?

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 adults with obesity or overweight who also have type 2 diabetes. Participants will be involved in the study for about 48 weeks.

Inclusion Criteria

Have an HbA1c ≥7.5% to ≤10.5% at screening

Have had a stable body weight (<5% body weight gain and/or loss) for the 3 months prior to screening

Have a BMI of 27 or greater at screening

Exclusion Criteria

I have a form of diabetes that is not type 2.

I had or plan to have weight loss surgery, but not liposuction or a tummy tuck unless it was over a year ago.

I haven't had a heart attack, stroke, severe chest pain, or heart failure hospitalization in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive macupatide and/or eloralintide, or placebo, subcutaneously for weight reduction

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eloralintide
• Macupatide

Trial Overview The study is testing weight reduction effects of two drugs, Macupatide and Eloralintide, alone or combined. It's to see how well they work in people with both obesity (or being overweight) and type 2 diabetes.

How Is the Trial Designed?

Group I: Macupatide + Eloralintide Experimental Treatment 2 Interventions

Participants will be administered eloralintide SC and macupatide SC

Group II: Macupatide (Macupatide + Eloralintide Placebo) Experimental Treatment 2 Interventions

Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC

Group III: Eloralintide (Elorlintide + Macupatide Placebo) Experimental Treatment 2 Interventions

Participants will be administered eloralintide SC and macupatide placebo SC

Group IV: Placebo (Macupatide Placebo + Elorlintide Placebo) Placebo Group 2 Interventions

Participants will be administered eloralintide placebo SC and macupatide placebo SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

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. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)02155-5/abstract

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 ...

2. lilly.gcs-web.com lilly.gcs-web.com/news-releases/news-release-details/lillys-selective-amylin-agonist-eloralintide-demonstrated

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% ...

3. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/eli-lilly-trial-eloralintide-weight-reduction-adults-obesity

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.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673625021555

Articles Eloralintide, a selective amylin receptor agonist for ... At 68 weeks, cagrilintide monotherapy provided an approximately 12% mean bodyweight loss. Eloralintide is a long-acting selective amylin ...

5. healio.com healio.com/news/endocrinology/20251106/novel-amylin-receptor-agonist-induces-clinically-meaningful-weight-loss

Novel amylin receptor agonist induces 'clinically ... Weight loss of 20% or more was achieved by 57% of the 9 mg eloralintide group and by 50% of those who received 6 mg eloralintide followed by 9 ...

6. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)02155-5/fulltext?rss=yes

Eloralintide, a selective amylin receptor agonist for the ... Here, we report the results of a phase 2 trial evaluating the efficacy and safety of a range of doses and dose escalation schemes of once-per- ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41109426/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1Jgu41lFGSj_ShZE4NRQ2hnLFGqOVFuKpoCzfmgi2UmEsRik-&fc=None&ff=20251027222541&v=2.18.0.post22+67771e2

Eloralintide (LY3841136), a novel amylin receptor agonist ... A phase 1, randomized, placebo-controlled, participant/investigator-blinded trial evaluated the safety and tolerability of single-ascending ...