Macupatide and eloralintide, alone or together, for weight loss in adults with type 2 diabetes
A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Reduction With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and With Type 2 Diabetes
This trial tests whether the drugs macupatide and eloralintide, alone or combined, help adults with overweight or obesity and type 2 diabetes lose weight over about 48 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 38 sites (Gilbert, Arizona and 37 other locations) |
| Trial ID | NCT07215559 on ClinicalTrials.gov |
What this trial studies
In this Phase 2 interventional trial adults with overweight or obesity and type 2 diabetes will receive macupatide, eloralintide, the two drugs in combination, or matched placebos for roughly 48 weeks. Study visits will monitor body weight, HbA1c, and safety measures while participants continue standard care (diet/exercise or stable metformin/SGLT2 therapy). The goal is to measure how much weight is lost and to track effects on blood sugar and adverse events. The design uses active and placebo injections to compare single-agent and combination effects on metabolic outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with type 2 diabetes (HbA1c 7.5–10.5%), a BMI ≥27, a stable weight for the prior 3 months, and on diet/exercise alone or a stable dose of metformin or an SGLT2 inhibitor.
Not a fit: Patients with other forms of diabetes, recent major cardiovascular events, recent or planned obesity surgery, active or recently treated malignancy, or who fall outside the HbA1c/BMI ranges are unlikely to qualify or benefit from this study.
Why it matters
Potential benefit: If successful, this approach could produce greater weight loss and improved blood sugar control for adults with overweight or obesity and type 2 diabetes.
How similar studies have performed: Other programs targeting incretin pathways (for example GLP-1/GIP agents) and amylin analogs have produced meaningful weight loss, but combining a GIP-directed agent like macupatide with an amylin analogue such as eloralintide is a newer strategy being tested in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have type 2 diabetes * Have an HbA1c ≥7.5% to ≤10.5% at screening * Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening * Diet and exercise * Stable dose of metformin * Sodium-glucose cotransporter-2 (SGLT2) inhibitor * 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: * Have any form of diabetes other than type 2 diabetes * Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening * Have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include * basal or squamous cell skin cancer * in situ carcinomas of the cervix, or * in situ prostate cancer * Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months: * amylin RA * dual amylin and calcitonin RA * glucagon-like peptide-1 receptor (GLP-1) RA * glucose-dependent insulinotropic peptide (GIP)/GLP-1 RA * GLP-1/glucagon (GCG) RAs, or * GIP/GLP-1/GCG RAs * Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides * Have used insulin for diabetic control within the prior year (short term use in certain situations allowed
Where this trial is running
Gilbert, Arizona and 37 other locations
- Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC — Gilbert, Arizona, United States (Recruiting)
- Synexus Clinical Research US, Inc. — Phoenix, Arizona, United States (Recruiting)
- Pima Heart — Tucson, Arizona, United States (Recruiting)
- SKY Clinical Research Network Group-Brown — Atlanta, Georgia, United States (Recruiting)
- Teak Research Consults — Lawrenceville, Georgia, United States (Recruiting)
- AGILE Clinical Research Trials, LLC — Sandy Springs, Georgia, United States (Recruiting)
- Pivotal Research Solutions — Stonecrest, Georgia, United States (Recruiting)
- Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States (Recruiting)
- Vector Clinical Trials — Las Vegas, Nevada, United States (Recruiting)
- Premier Research — Trenton, New Jersey, United States (Recruiting)
- Mercy Family Clinic — Dallas, Texas, United States (Recruiting)
- Velocity Clinical Research, Dallas — Dallas, Texas, United States (Recruiting)
- PlanIt Research, PLLC — Houston, Texas, United States (Recruiting)
- Aavon Clinical Trials — Richmond, Texas, United States (Recruiting)
- Consano Clinical Research, LLC — Shavano Park, Texas, United States (Recruiting)
- Texas Valley Clinical Research — Weslaco, Texas, United States (Recruiting)
- Kalo Clinical Research — West Valley City, Utah, United States (Recruiting)
- Eastern Virginia Medical School (EVMS) Medical Group — Norfolk, Virginia, United States (Recruiting)
- Clinical Research Partners, LLC — Richmond, Virginia, United States (Recruiting)
- Northwest Clinical Research Center — Bellevue, Washington, United States (Recruiting)
- Rainier Clinical Research Center — Renton, Washington, United States (Recruiting)
- Universal Research Group — Tacoma, Washington, United States (Recruiting)
- Centro de Investigaciones Metabólicas (CINME) — Buenos Aires, Argentina (Recruiting)
- Cenudiab — Buenos Aires, Argentina (Recruiting)
- Cedic — Caba, Argentina (Recruiting)
- Instituto de Investigaciones Clínicas Córdoba — Córdoba, Argentina (Recruiting)
- Clínica Universitaria Reina Fabiola — Córdoba, Argentina (Recruiting)
- Go Centro Medico San Nicolás — San Nicolás, Argentina (Recruiting)
- Emeritus Research — Botany, Australia (Recruiting)
- Core Research Group — Brisbane, Australia (Recruiting)
- Emeritus Research — Camberwell, Australia (Recruiting)
- Cornerstone Dermatology — Coorparoo, Australia (Recruiting)
- Momentum Darlinghurst — Darlinghurst, Sydney, Australia (Recruiting)
- CDH Research Institute Pty Ltd — Maroochydore, Australia (Recruiting)
- Momentum Sunshine — Melbourne, Australia (Recruiting)
- AIM Research — Merewether, Australia (Recruiting)
- San Juan Bautista School of Medicine - Clinical Research Unit — Caguas, Puerto Rico (Recruiting)
- Mgcendo Llc — San Juan, Puerto Rico (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.