A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants Wit… (NCT05803421) | Clinical Trial Compass
CompletedPhase 3
A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
United States, Argentina, Austria2,749 participantsStarted 2023-04-03
Plain-language summary
The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have been diagnosed with type 2 diabetes mellitus (T2DM)
* Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.
* Have HbA1c at screening
* ≥7.0% and ≤10.5% if background diabetes medication does not include a sulfonylurea, or
* ≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea.
* Are on stable treatment of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 90 days before screening. Antihyperglycemic drugs may include metformin, SGLT-2 inhibitors, and/or sulfonylureas
* Have increased risk for cardiovascular (CV) events due to:
* Coronary heart disease
* Peripheral arterial disease, presumed to be of atherosclerotic origin
* Cerebrovascular disease, presumed to be of atherosclerotic origin
* Chronic kidney disease (CKD)
* Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III
* Are of stable weight (± 5%) for at least 90 days prior to screening
* Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening
Exclusion Criteria:
* Have type 1 diabetes mellitus
* Have had chronic or acute pancreatitis any time prior to screening
* Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-VEGF inhibitors
* Have a known clinically significant gastric emptying abnormalit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]
Timeframe: Baseline to End of the Study (Approximate Maximum 104 Weeks)