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Clinical Trials/jRCT2031250801
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

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

Sponsor
Not provided

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