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Clinical Trials List

Protocol NumberJ3R-MC-YDAN
NCT Number(ClinicalTrials.gov Identfier)NCT07353931
Not yet recruiting

2026-03-01 - 2029-01-25

Phase III

Recruiting7

A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Osteoarthritis Knee Pain, and Obesity or Overweight (ENLIGHTEN-4)

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/10

Investigators and Locations

Principal Investigator Chi-Ching Chang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張櫻霖

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳玉秀

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 盧佳文

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳英州

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Yuan Lin

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳柏廷

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Osteoarthritis 、Overweight or Obesity

Objectives

YDAN主要試驗計畫書支持兩項獨立試驗:J3R-MC-YOA1和J3R-MC-YOA2。每項試驗都將研究在患有肥胖或過重和退化性膝關節炎(OA)疼痛的成人中,Eloralintide (LY3841136)的療效和安全性。參與試驗的期間將持續約75週(包括篩選)。

Test Drug

預充填式注射劑
預充填式注射劑

Active Ingredient

Eloralintide (LY3841136)
Placebo

Dosage Form

230
230

Dosage

MG

Endpoints

結果測量:體重自基準期以來的百分比變化
結果測量測量說明:體重自基準期以來的百分比變化
時間範圍:基準期,第64週

結果測量:西安大略及麥肯馬司特大學退化性關節炎量表(WOMAC)疼痛子量表分數自基準期以來的變化
結果測量測量說明:WOMAC疼痛子量表分數自基準期以來的變化
時間範圍:基準期,第64週

Inclution Criteria

Inclusion Criteria:

Have a body mass index (BMI) of 27 kilograms per square meter (kg/m²) or higher at screening
Have a stable body weight (less than 5% body weight change) for 90 days prior to screening
Have tried at least once to lose weight through diet but were unsuccessful
Have osteoarthritis of the knee and at least one of the following conditions:

Be over 50 years old
Have morning knee stiffness that lasts about 30 minutes
Have a crackling or grinding sound or feeling in the knee

Exclusion Criteria

Exclusion Criteria:

Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed greater than 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, type 2 diabetes, or any other type of diabetes
Have an active knee infection
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

The Estimated Number of Participants

  • Taiwan

    69 participants

  • Global

    900 participants