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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

- Have a crackling or grinding sound or feeling in the knee.

Exclusion Criteria:

- 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.

- Have had a recent heart condition or New York Heart Association Functional Classification Class IV congestive heart failure.

- Have used any glucagon-like peptide-1 (GLP-1) receptor agonist medication within 180 days of screening

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07153471
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, China, Germany, India, Japan, Mexico, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Orforglipron (GZT1)

Participants will receive orforglipron orally

Placebo Comparator: Placebo (GZT1)

Participants will receive placebo orally

Experimental: Orforglipron (GZT2)

Participants will receive orforglipron orally

Placebo Comparator: Placebo (GZT2)

Participants will receive placebo orally

Interventions

Drug: - Orforglipron

Administered orally

Drug: - Placebo

Administered orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arizona Research Center, Phoenix 5308655, Arizona 5551752

Status

Not yet recruiting

Address

Arizona Research Center

Phoenix 5308655, Arizona 5551752, 85053

Site Contact

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