A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Overweight
Obesity
Спонсор: Eli Lilly and Company
Налично на:
БГ
Обобщение
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.
Кой може да участва
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