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A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

ConditionOsteoarthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Be over 50 years old

Have morning knee stiffness that lasts about 30 minutes

Disqualifiers

Have gained or lost more than 11 pounds within 90 days prior to screening

Have had a surgery for obesity or plan to have one in the next 18 months

Have an active knee infection

Have type 1 diabetes, type 2 diabetes, or any other type of diabetes

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orforglipron

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally

Treatment groups

800 Participants
are divided into 4 treatment groups
Group A: Orforglipron (GZT1)Experimental treatment 1 intervention
Group B: Placebo (GZT1)Placebo comparator 1 intervention
Group C: Orforglipron (GZT2)Experimental treatment 1 intervention
Group D: Placebo (GZT2)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

Time frame
Baseline, Week 72

Secondary outcomes

1

Change from Baseline in the WOMAC Physical Function Subscale Score

Time frame
Baseline, Week 72
2

Percent Change from Baseline in Body Weight

Time frame
Baseline, Week 72
3

Change from Baseline in 36-item, Short-Form Health Survey, version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

Time frame
Baseline, Week 72
4

Change from Baseline in Distance Walked During the 6-Minute Walk Test

Time frame
Baseline, Week 72

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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