jRCT2031250801
Recruiting
Not Applicable
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes (J3R-MC-YDAG)
Not provided0 sites1,980 target enrollmentStarted: TBD
ConditionsObesity
Overweight
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,980
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Have Body Mass Index (BMI) at screening of the following:
- •30 kilogram per square meter (kg/m2) OR
- •27 kg/m2 with at least one of the following weight-related health conditions at screening:
- •high blood pressure
- •dyslipidemia
- •obstructive sleep apnea, or
- •heart disease
- •Have a stable body weight (<5% body weight change) for 90 days prior to screening.
- •Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight
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 or type 2 diabetes
- •Have had within 90 days prior to screening:
- •heart attack
- •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
Investigators
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