A study of LY3502970 in Obese or Overweight and Diabetes Patients

Phase 3

Active, not recruiting

• Conditions: Overweight and obesity,

• Registration Number: CTRI/2023/11/060209
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-15
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Have a BMI ≥27.0 kg/m² 2.
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
• Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of: either diet/exercise alone or up to 3 oral antihyperglycemic medications (excluding DPP-4i or GLP-1 RA).

Exclusion Criteria

• Have Type 1 Diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
• Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of anti- vascular endothelial growth factor inhibitors).
• Have family (first-degree relative) or personal history of MTC or MEN2 syndrome.
• Have had a history of chronic or acute pancreatitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Percent Change from Baseline in Body Weight	Baseline, Week 72

Secondary Outcome Measures

Name	Time	Method
1. Mean Change from Baseline in Waist Circumference	2. Mean Change from Baseline in Hemoglobin A1c (HbA1c) %

Trial Locations

Locations (12)

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

Arthur Asirvatham Hospital; 🇮🇳 Madurai, TAMIL NADU, India

Bhaikaka University, Shree Krishna Hospital and Medical Research Center; 🇮🇳 Anand, GUJARAT, India

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

Department of Medicine, Government Medical College, Aurangabad; 🇮🇳 Aurangabad, MAHARASHTRA, India

Diabetes Research Center; 🇮🇳 Hyderabad, TELANGANA, India

Fortis Hospital; 🇮🇳 Delhi, DELHI, India

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

Medstar Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sahyadri Super Speciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

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All India Institute of Medical Sciences (AIIMS) - Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

Dr Rajashree Sanjay Khot

Principal investigator

9823134598

rajashree.s.khot@gmail.com