A Study of LY3437943 in Obese or Overweight Patients

Phase 3

Active, not recruiting

• Conditions: Overweight and obesity,

• Registration Number: CTRI/2023/11/059873
• 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 who have obesity or overweight (J1I-MC-GZBJ master protocol). This study will last about 89 weeks and will include up to 24 visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-18
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

• Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following: hypertension, dyslipidemia obstructive sleep apnea, or cardiovascular disease 2.
• History of at least one unsuccessful dietary effort to reduce body weight.

Exclusion Criteria

• Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days.
• Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
• Have a prior or planned surgical treatment for obesity.
• Have diabetes mellitus.
• Have 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
1. Change from Baseline in Body Mass Index (BMI)	2. Change from Baseline in Waist Circumference
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)	Baseline through Week 80

Trial Locations

Locations (14)

All India Institute of Medical Sciences; 🇮🇳 Khordha, ORISSA, India

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

Chellaram Diabetes Institute; 🇮🇳 Pune, MAHARASHTRA, India

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

Deenanath Mangeshkar Hospital & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Endolife Speciality Hospitals Pvt. Ltd.; 🇮🇳 Guntur, ANDHRA PRADESH, India

Eternal Hospital, Unit of Eternal Heart Care Center and Research Institute Pvt. Ltd.; 🇮🇳 Jaipur, RAJASTHAN, India

ILS Hospital, Saltlake; 🇮🇳 Kolkata, WEST BENGAL, India

Indian Institute of Diabetes; 🇮🇳 Thiruvananthapuram, KERALA, India

Jothydevs Diabetes Research Centre; 🇮🇳 Thiruvananthapuram, KERALA, India

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All India Institute of Medical Sciences

🇮🇳Khordha, ORISSA, India

Dr Kishore Kumar Behra

Principal investigator

919583644988

kkbaims@gmail.com