JRCT ID: jRCT2051250177
Registered date:24/12/2025
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Overweight Obesity |
| Date of first enrollment | 23/03/2026 |
| Target sample size | 1035 |
| Countries of recruitment | United States,Japan,Argentina,Japan,China,Japan,Czechia,Japan,Germany,Japan,India,Japan,Mexico,Japan,Poland,Japan,Puerto Rico,Japan,Slovakia,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan |
| Study type | Interventional |
| Intervention(s) | DRUG: Eloralintide(Other Name: LY3841136) Administered SC DRUG: Placebo Administered SC (Study Arms) Experimental: Eloralintide Dose 1 Participants will receive eloralintide subcutaneously (SC) Interventions: Drug: Eloralintide Experimental: Eloralintide Dose 2 Participants will receive eloralintide SC Interventions: Drug: Eloralintide Experimental: Eloralintide Dose 3 Participants will receive eloralintide SC Interventions: Drug: Eloralintide Experimental: Eloralintide Dose 4 Participants will receive eloralintide SC Interventions: Drug: Eloralintide Placebo Comparator: Placebo Participants will receive placebo SC Interventions: Drug: Placebo |
Outcome(s)
| Primary Outcome | Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 64 |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | - Have type 2 diabetes - Are on stable treatment for type 2 diabetes for at least 90 days prior to screening - Have a BMI >= 27 kg/m2 - Have a stable body weight (<5% body weight change) for 90 days prior to screening |
| Exclude criteria | - Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening) - Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening) - Have type 1 diabetes - Have taken any of the following antihyperglycemic medications within 90 days before screening: * amylin analogs * glucagon-like peptide-1 (GLP-1) receptor agonists * glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or * insulin - Have had within 90 days prior to screening: * heart attack * stroke * coronary artery revascularization * unstable angina, or * hospitalization due to congestive heart failure - Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure - Have taken medications or alternative remedies intended for weight loss within 90 days of screening |
Related Information
| Primary Sponsor | Masaki Takeshi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) | NCT07282600 |
Contact
| Public contact | |
| Name | Trial Guide Call Center |
| Address | 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086 |
| Telephone | +81-120-023-812 |
| LTG_CallCenter@lists.lilly.com | |
| Affiliation | Eli Lilly Japan K.K. |
| Scientific contact | |
| Name | Takeshi Masaki |
| Address | 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086 |
| Telephone | +81-120-023-812 |
| LTG_CallCenter@lists.lilly.com | |
| Affiliation | Eli Lilly Japan K.K. |