Obesity, Osteo Arthritis Knee, Overweight
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks.
Interventions
DRUGRetatrutide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a body mass index (BMI) ≥27 kilogram/kg/m² at screening. * Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. * Have index knee pain for \>12 weeks prior to screening, and presence of index knee pain for \>15 days over the previous month. * Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening. * Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.
Exclusion criteria
* Have had steroid joint injections within 90 days of screening. * Have had other joint injections and procedures within 6 months of screening. * Have joint disease other than osteoarthritis. * Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days prior to screening. * Have been taking weight loss drugs, including over-the-counter medications, within 90 days prior to screening. * Have a prior or planned surgical treatment for obesity. * Have diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score | Baseline, Week 68 |
| Percent Change from Baseline in Body Weight | Baseline, Week 68 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in the WOMAC Physical Function Subscale Score | Baseline, Week 68 |
| Change from Baseline in Waist Circumference | Baseline, Week 68 |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 68 |
| Percent Change from Baseline in Triglycerides | Baseline, Week 68 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 68 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 68 |
| Change from Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 68 |
| Percent Change from Baseline in Fasting Insulin | Baseline, Week 68 |
| Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | Baseline, Week 68 |
| Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score | Baseline, Week 68 |
| Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score | Baseline, Week 68 |
Countries
Australia, Canada, Mexico, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed