A Study of Orforglipron (LY3502970) in Adults With Type 2 Diabetes

Phase 3

Active, not recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2024/01/061307
• Lead Sponsor: Eli Lilly Company India Pvt Ltd

Brief Summary

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-15
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

• Have Type 2 Diabetes.
• Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
• Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
• Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
• Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria

• Have Type 1 Diabetes.
• Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
• Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
• Have New York Heart Association functional classification IV congestive heart failure.
• Have acute or chronic hepatitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 40

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Fasting Serum Glucose	Percentage Change from Baseline in Body Weight
Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)	Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol)

Trial Locations

Locations (10)

All India Institute of Medical Sciences (AIIMS) - Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

B.J. Medical College & Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

BSES Municipal General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Diabetes Research Center; 🇮🇳 Hyderabad, TELANGANA, India

GMERS Medical College and General Hospital Gotri; 🇮🇳 Vadodara, GUJARAT, India

Grant Medical Foundation - Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Institute of Post Graduate Medical Education and Research; 🇮🇳 Kolkata, WEST BENGAL, India

M S Ramaiah Medical College and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Madras Diabetes Research Foundation; 🇮🇳 Chennai, TAMIL NADU, India

Medstar Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

All India Institute of Medical Sciences (AIIMS) - Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

Dr Udit Narang

Principal investigator

9970505548

uditnarang@gmail.com