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A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Overweight, Obesity

Interventions: Eloralintide, Placebo

Countries: United States, Argentina, China, Czechia, Germany, India, Japan, Mexico

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion 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

Exclusion 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

Locations (159)

Birmingham, Alabama, United States
Cullman, Alabama, United States
Tucson, Arizona, United States
Canoga Park, California, United States
Escondido, California, United States
Greenbrae, California, United States
Long Beach, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Santa Clarita, California, United States
Spring Valley, California, United States
Walnut Creek, California, United States
Aurora, Colorado, United States
Bridgeport, Connecticut, United States
Hamden, Connecticut, United States
Daytona Beach, Florida, United States
Delray Beach, Florida, United States
Fleming Island, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Mt. Dora, Florida, United States
Pembroke Pines, Florida, United States
Winter Park, Florida, United States
Dunwoody, Georgia, United States
Lawrenceville, Georgia, United States
Macon, Georgia, United States
Honolulu, Hawaii, United States
Skokie, Illinois, United States
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