A study of LY3502970 in Participants with Obesity or Overweight
- Conditions
- Body mass index [BMI],
- Registration Number
- CTRI/2023/12/060509
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
From 1998 to 2018, the prevalence of obesity is rapidly spurting due to sedentary lifestyle and consumption of high calories food. In India, more than 135 million individuals were affected by obesity. Treatment with glucagon-like peptide-1 receptor agonist and dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonists has shown body weight reduction of a greater magnitude compared to conventional pharmacologic anti-obesity therapies. Despite these advancements, bariatric surgery, such as RY-gastric bypass or sleeve gastrectomy remains the only approved treatment that achieves average body weight reduction of 30 to 32%. There remains an unmet medical need for pharmacologic treatments that are safe, efficacious, and well tolerated in patients with overweight and obesity. Hence, this study which aims to investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities is hopeful to clarify its safety and efficacy in order to be considered as a potential treatment candidate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 3000
- Have a BMI ≥30.0 kilogram/square meter (kg/m²), or ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening: Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma 2.
- Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
- 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 to Week 72
- Secondary Outcome Measures
Name Time Method 1. Mean Change from Baseline in Waist Circumference 2. Mean Change from Baseline in Systolic Blood Pressure (SBP)
Trial Locations
- Locations (10)
All India Institute of Medical Sciences (AIIMS) - Bhubaneswar
🇮🇳Khordha, ORISSA, India
All India Institute of Medical Sciences (AIIMS) - Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳Pune, MAHARASHTRA, India
Endolife Speciality Hospitals Pvt. Ltd.
🇮🇳Guntur, ANDHRA PRADESH, India
Government Medical College and Hospital – Nagpur (Internal Medicine)
🇮🇳Nagpur, MAHARASHTRA, India
Grant Govt. Medical College and Sir J.J. Group of Hospitals
🇮🇳Mumbai, MAHARASHTRA, India
K.R. Hospital, Attached to Mysore Medical College and Research Institute
🇮🇳Mysore, KARNATAKA, India
Lifepoint Multispecialty Hospital
🇮🇳Pune, MAHARASHTRA, India
Sahyadri Super Speciality Hospital (Sahyadri Clinical Research and Development Center)
🇮🇳Pune, MAHARASHTRA, India
Victoria Hospital, Bangalore Medical College and Research Institute
🇮🇳Bangalore, KARNATAKA, India
All India Institute of Medical Sciences (AIIMS) - Bhubaneswar🇮🇳Khordha, ORISSA, IndiaDr Debasish HotaPrincipal investigator9438884190debhota@gmail.com