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A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin
A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin

NCT07392190

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Overweight, Obesity

Interventions: Eloralintide, Placebo

Countries: United States, Australia, Belgium, Brazil, China, Czechia, India, Israel

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy. Participation in the study will last about 80 weeks.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Are on stable incretin therapy at screening
* With persistent obesity or overweight defined as:

  * ≥30 kg/m2 OR
  * ≥27 kg/m2 with at least one existing obesity related complication at screening:

    * hypertension
    * dyslipidemia
    * obstructive sleep apnea
    * cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or
    * type 2 diabetes
* Have a stable body weight (\<5% body weight change) at 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:

  * dipeptidyl peptidase-4 (DPP-4) inhibitors
  * amylin analogs
  * 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
Locations (187)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • Irvine, California, United States
  • La Jolla, California, United States
  • La Mesa, California, United States
  • Rolling Hills Estates, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • Santa Ana, California, United States
  • Tustin, California, United States
  • Bridgeport, Connecticut, United States
  • New Haven, Connecticut, United States
  • Waterbury, Connecticut, United States
  • Atlantis, Florida, United States
  • Doral, Florida, United States
  • Fleming Island, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Saint Augustine, Florida, United States
  • West Palm Beach, Florida, United States
  • Dunwoody, Georgia, United States
  • Gainesville, Georgia, United States
  • Stockbridge, Georgia, United States
  • Idaho Falls, Idaho, United States
  • Chicago, Illinois, United States
  • West Des Moines, Iowa, United States
  • Topeka, Kansas, United States
  • Lexington, Kentucky, United States
  • + 157 more on CT.gov