Recruiting

ATTAIN-OA PAINOrforglipron for Obesity and Knee Osteoarthritis

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Study Aim

This study aims to evaluate the effectiveness of Orforglipron in treating obesity and knee osteoarthritis in adults.

What is being tested

Orforglipron

+ Placebo

Drug
Who is being recruted

Arthritis+10

+ Body Weight

+ Joint Diseases

Over 18 Years
1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 15, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a medication called orforglipron to see how effective and safe it is for people who are either obese or overweight and also suffer from knee osteoarthritis, a common cause of knee pain. Osteoarthritis is a condition where the joint cartilage breaks down, leading to pain and stiffness. By studying this medication, researchers aim to potentially provide a new treatment option that could help alleviate knee pain and improve the quality of life for those affected by both obesity and osteoarthritis. Participants in the study will take orforglipron once a day, and the trial will last for about 74 weeks. During this time, participants will be closely monitored to evaluate the effectiveness of the medication in reducing knee pain and its overall safety. The study is designed as a double-blind trial, meaning neither the participants nor the researchers know who is receiving the actual medication or a placebo, which helps ensure unbiased results. The study aims to gather comprehensive data on the potential benefits and any side effects of orforglipron in treating knee osteoarthritis in individuals with obesity or overweight.

Official TitleA Phase 3 Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Trial
NCT07153471
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

800 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBody WeightJoint DiseasesMusculoskeletal DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesityOsteoarthritisRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

1 inclusion criteria required to participate
Have a body mass index (BMI) of 27 kilograms per square meter (kg/m2) or higher at screening

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive orforglipron orally

Group II

Experimental
Participants will receive orforglipron orally

Group III

Placebo
Participants will receive placebo orally

Group IV

Placebo
Participants will receive placebo orally

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 94 locations

Recruiting

Arizona Research Center

Phoenix, United StatesOpen Arizona Research Center in Google Maps
Recruiting

AMR Clinical

Tempe, United States
Recruiting

Care Access - Huntington Beach

Huntington Beach, United States
Recruiting

Care Access - Thousand Oaks

Thousand Oaks, United States
Recruiting
94 Study Centers