A Study of LY3437943 in Participants with Type 2 Diabetes Mellitus who have Obesity or Overweight

Phase 3

Recruiting

• Conditions: Type 2 diabetes mellitus,

• Registration Number: CTRI/2023/10/058324
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes who have obesity or overweight (J1I-MC-GZBK master protocol). The study will last about 89 weeks and will include up to 24 visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-20
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m²) 2.
• Have Type 2 Diabetes (T2D) 3.
• Are on stable treatment for T2D for at least 90 days 4.
• Have a history of at least one unsuccessful dietary effort to lose body weight.

Exclusion Criteria

• Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days 2.
• Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening 3.
• Have a prior or planned surgical treatment for obesity 4.
• Have Type 1 diabetes.
• Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) 6.
• Have had pancreatitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline, Week 80

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)	Baseline through Week 80
1. Change from Baseline in Body Mass Index (BMI)	2. Change from Baseline in Waist Circumference

Trial Locations

Locations (14)

All India Institute of Medical Sciences, Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

Avron Hospitals Pvt. Ltd.; 🇮🇳 Ahmadabad, GUJARAT, India

CARE CHL-Hospitals (Unit of Convenient Hospitals Ltd.); 🇮🇳 Indore, MADHYA PRADESH, India

CARE Out Patient Center, Care Hospitals Hyderabad – Banjara Hills; 🇮🇳 Hyderabad, TELANGANA, India

Christian Medical College, Vellore; 🇮🇳 Vellore, TAMIL NADU, India

Diabetes Research Center; 🇮🇳 Hyderabad, TELANGANA, India

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

K R Hospital (Mysore Medical College and Research Institute); 🇮🇳 Mysore, KARNATAKA, India

Life Care Hospital and Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

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

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All India Institute of Medical Sciences, Raipur

🇮🇳Raipur, CHHATTISGARH, India

Dr Md Sabah Siddiqui

Principal investigator

918518881911

dr.sabahsiddiqui@gmail.com