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Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight

Plain-language guide to NCT07353931: phase 3 randomized trial of Eloralintide, 900 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07353931
Phase
phase 3
Status
recruiting participants
Start
2026-02-09
Completion (planned or actual)
2028-03
Participants
900 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Osteoarthritis; Overweight or Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Eloralintide.

The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2.

Participation in the study will last about 75 weeks, including screening.

It had four arms (groups): Eloralintide (YOA1) (experimental), Placebo (YOA1) (placebo comparator), Eloralintide (YOA2) (experimental) and Placebo (YOA2) (placebo comparator).

Participants will receive eloralintide subcutaneously (SC).

Participants will receive placebo SC.

Participants will receive eloralintide SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 900 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have a body mass index (BMI) of 27 kilograms per square meter (kg/m²) or higher at 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.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed greater than 1 year before screening); have type 1 diabetes, type 2 diabetes, or any other type of diabetes; have an active knee infection.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Eloralintide group and the comparison group should start out alike.

The Eloralintide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Eloralintide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2026-02-09 with completion listed for 2028-03.

It ran at 153 sites in United States (39), China (23), Japan (15), Argentina (14), Belgium (8) and Germany (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change from Baseline in Body Weight (time frame: Baseline, Week 64). Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score (time frame: Baseline, Week 64).

It also tracked 24 secondary outcomes, for example Change from Baseline in Systolic Blood Pressure (SBP), Percent Change from Baseline in Triglycerides, Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score, Percent Change from Baseline in High Sensitivity, C-reactive Protein (hsCRP), Change from Baseline in the WOMAC Physical Function Subscale Score and Change from Baseline WOMAC Pain Subscale Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Eloralintide in 900 people.

With 900 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Eloralintide compound page, all human trials.

Our Notes on the Compound

Eloralintide: An investigational selective amylin-receptor agonist studied in once-weekly phase 2 obesity trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.