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Clinical Trials in India / NCT07613307
Recruiting Phase 3

A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting

NCT07613307 · tracked via the Priya Life Science India tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2026-07-15
Last updated
2026-09-08

Condition(s) studied

Diabetes Mellitus, Type 2Diabetes MelletusGlucose Metabolism DisordersMetabolic DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesFeeding BehaviorBehaviorFastingGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsReceptors, Peptide

Investigational drug(s) / intervention(s)

Orforglipron

Orforglipron: Administered orally

Study summary

The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards. * Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol/mol)) to less than 9.5% (91 mmol/mol) at screening. * Intend to be compliant with the fast during the Ramadan period. * Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening. * Have body mass index (BMI) of 25 kilograms per meter square (kg/m2) or higher at screening. Exclusion Criteria: * Have any form of diabetes other than T2D, including type 1 diabetes (T1D), gestational diabetes, latent autoimmune diabetes, maturity-onset diabetes of the young, and medication-induced diabetes * Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. * Have a history of chronic or acute pancreatitis any time prior to screening * Have evidence of a significant, uncontrolled endocrine abnormality, for example, thyrotoxic or adrenal crises, in the opinion of the investigator * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years. * Have a history of cholecystectomy (surgically removed gallbladder) * Have New York Heart Association Functional Classification IV congestive heart-failure.

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Sarojini Naidu Medical College Agra India Recruiting
Osmania General Hospital Hyderabad India Recruiting
Brij Medical Centre Pvt. Ltd. Kanpur India Recruiting
Apollo Multispeciality Hospitals limited Kolkata India Recruiting
KGN Diabetes and Endocrinology Centre Mumbai India Recruiting
Mysore Medical College and Research Institute Mysore India Recruiting
Supe Heart & Diabetes Hospital & Research Centre Nashik India Recruiting
Diabetes Clinic Nellore India Recruiting
Visakha Institute of Medical Sciences Visakhapatna India Recruiting
King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs Al-Ahsa Saudi Arabia Not Yet Recruiting
King Fahad Specialist Hospital Dammam Saudi Arabia Recruiting
Imam Abdulrahman Bin Faisal University Dammam Saudi Arabia Recruiting
National Guard Health Affairs: King Abdulaziz Medical City Jeddah Saudi Arabia Not Yet Recruiting
King Abdulaziz University Hospital Jeddah Saudi Arabia Recruiting
King Fahad Armed Forces Hospital Jeddah Jeddah Saudi Arabia Not Yet Recruiting
Dr. Soliman Fakeeh Hospital Jeddah Saudi Arabia Recruiting
King Saud University Medical City Riyadh Saudi Arabia Recruiting
Dr. Soliman Fakeeh Hospital Riyadh Saudi Arabia Not Yet Recruiting
Osepdale Fatebenefratelli e Oftalmico Riyadh Saudi Arabia Not Yet Recruiting
JOSHA Research Bloemfontein South Africa Recruiting
TREAD Research Cape Town South Africa Recruiting
TASK Central Cape Town South Africa Recruiting
Tiervlei Trial Centre Cape Town South Africa Recruiting
Synopsis Research Cape Town South Africa Recruiting
Synergy Biomed Research Institute (SBRI) East London South Africa Recruiting
Aliwal Shoal Medical Centre eMkhomazi South Africa Recruiting
Fola Health Johannesburg South Africa Not Yet Recruiting
Trident Clinical Kimberley South Africa Recruiting
Ubuntu Clinical Research Krugersdorp Krugersdorp South Africa Recruiting
Drs H & V Makan Centre for Diabetes Lenasia South Africa Recruiting
Be Part Research (PTY) LTD Paarl South Africa Recruiting
Emmed Research Pretoria South Africa Recruiting
Dr JM Engelbrecht Trial Site Somerset West South Africa Recruiting
Burjeel Medical City Abu Dhabi United Arab Emirates Not Yet Recruiting
NMC Royal hospital Abu Dhabi United Arab Emirates Not Yet Recruiting
Sheikh Khalifa Medical City Abu Dhabi United Arab Emirates Recruiting
NMC Abu Dhabi Abu Dhabi United Arab Emirates Recruiting
Tawam Hospital Al Ain City United Arab Emirates Recruiting
Emirates Hospital Dubai Dubai United Arab Emirates Not Yet Recruiting
Dubai Hospital Dubai United Arab Emirates Not Yet Recruiting

More Eli Lilly and Company trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07613307 on ClinicalTrials.gov ↗ ← All trials in India