A Study of LY3502970 Versus Insulin Glargine in Adult Participants with Type 2 Diabetes and Obesity or Overweight

Phase 3

Recruiting

• Conditions: Type 2 diabetes mellitus,

• Registration Number: CTRI/2023/10/058480
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief 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.

Remarks: CT-NOC conditional approval was provided for protocol J2A-MC-GZGS with one of the conditions outlined being that the Principal investigator (PI) should be cardiologist and Co-Investigator (Co-I) should be endocrinologist in each site in the proposed study. Thus, to comply with this condition, PI for all sites have been changed to cardiologists with previous encrocrinologists having their role switched to Co-I. These individual site PI change requests have been notified to respective site ECs and to the DCGI. Thus, the PI’s listed in this CTRI application are the updated cardiologists that will function as the PI of these sites for the J2A-MC-GZGS study.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-30
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 2620

Inclusion Criteria

• Have been diagnosed with type 2 diabetes mellitus (T2DM) 2.
• 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 of ≥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 5.
• 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 6.
• Are of stable weight (± 5%) for at least 90 days prior to screening 7.
• Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening.

Exclusion Criteria

• Have type 1 diabetes mellitus 2.
• Have had chronic or acute pancreatitis any time prior to screening 3.
• 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 4.
• Have a known clinically significant gastric emptying abnormality 5.
• Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) or aspartate aminotransferase (AST) enzyme level ≥5.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory 6.
• Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure 7.
• Have an eGFR <15 mL/min/1.73 m2 as determined at screening 8.
• Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 9.
• Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days 10.
• Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death]	Baseline to End of the Study (Approximate Maximum 104 Weeks)

Secondary Outcome Measures

Name	Time	Method
Time to First Occurrence of Any MACE-3 Event (MI, Stroke, or CV death)	Baseline to End of the Study (Approximately 104 Weeks)
1. Change from Baseline in HbA1c	2. Change from Baseline in Fasting Serum Glucose
Pharmacokinetics (PK): Plasma Serum Concentrations of Orforglipron	Baseline through Week 52
1. Percentage of Participants with HbA1c Target Values Less Than 7.0% (53 mmol/mol)	2. Percent Change from Baseline Body Weight

Trial Locations

Locations (12)

Apollo Excelcare Hospital; 🇮🇳 Kamrup, ASSAM, India

Central India Cardiology and Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

Chellaram Diabetes Institute; 🇮🇳 Pune, MAHARASHTRA, India

Department of Endocrinology, SMS Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Eternal Hospital, Unit of Eternal Heart Care Centre and Research Institute Private Limited; 🇮🇳 Jaipur, RAJASTHAN, India

Karnataka Institute of Medical Sciences; 🇮🇳 Dharwad, KARNATAKA, India

Lifecare Hospital And Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Nirmal Hospital Private Limited; 🇮🇳 Surat, GUJARAT, India

SCB Medical College and Hospitals; 🇮🇳 Cuttack, ORISSA, India

Seth G.S. Medical College and KEM Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

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Apollo Excelcare Hospital

🇮🇳Kamrup, ASSAM, India

Dr Neil Bardoloi

Principal investigator

9435703742

n.bardoloi.clinicalresearch@gmail.com