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

NCT07613307 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: 27746J2A-MC-GZPV
• Study Type: interventional
• Target: 130
• Locations: 4 countries
• Sites: 37

Brief 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.

Conditions

Diabetes Melletus; Metabolic Disorders; Endocrine System Diseases; Feeding Behavior; Fasting; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Behavior; Glucagon-Like Peptide-1 Receptor; Receptors, Peptide

Keywords

Ramadan; Fasting

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Hemoglobin A1C (HbA1c)

  Baseline, up to 8 Weeks after Start of Ramadan

Secondary Outcomes (6)

• Percentage of Participants with an HbA1c of less than (<) 7 Percent (%) (53 millimeters per mole (mmol/mol))

  Baseline, Up to 8 Weeks after Start of Ramadan

• Change From Baseline in Fasting Serum Glucose (FSG)

  Baseline, Up to 8 Weeks after Start of Ramadan

• Percent Change from Baseline in Body Weight

  Baseline, Up to 8 Weeks after Start of Ramadan

• Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index

  Baseline, Up to 8 Weeks after Start of Ramadan

• Percent Change in HbA1c

  4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]

Study Arms (1)

Orforglipron

EXPERIMENTAL

Administered orally

Drug: Orforglipron

Interventions

Orforglipron DRUG

Administered orally

Also known as: LY3502970

Orforglipron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 family (first-degree relative) or personal history of medullary thyroid carcinoma
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (37)

Sarojini Naidu Medical College

Agra, 282003, India

Location

Osmania General Hospital

Hyderabad, 500012, India

Location

Brij Medical Centre Pvt. Ltd.

Kanpur, 208020, India

Location

Apollo Multispeciality Hospitals limited

Kolkata, 700054, India

Location

KGN Diabetes and Endocrinology Centre

Mumbai, 400008, India

Location

Mysore Medical College and Research Institute

Mysore, 570001, India

Location

Supe Heart & Diabetes Hospital & Research Centre

Nashik, 422002, India

Location

Diabetes Clinic

Nellore, 524001, India

Location

Visakha Institute of Medical Sciences

Visakhapatna, 530040, India

Location

King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs

Al-Ahsa, 31982, Saudi Arabia

Location

King Fahad Specialist Hospital

Dammam, 32253, Saudi Arabia

Location

National Guard Health Affairs: King Abdulaziz Medical City

Jeddah, 21423, Saudi Arabia

Location

Dr. Soliman Fakeeh Hospital

Jeddah, 21461, Saudi Arabia

Location

King Abdulaziz University Hospital

Jeddah, 22254, Saudi Arabia

Location

King Fahad Armed Forces Hospital Jeddah

Jeddah, 23311, Saudi Arabia

Location

King Saud University Medical City

Riyadh, 11472, Saudi Arabia

Location

Dr. Soliman Fakeeh Hospital

Riyadh, 11564, Saudi Arabia

Location

Osepdale Fatebenefratelli e Oftalmico

Riyadh, 12231, Saudi Arabia

Location

JOSHA Research

Bloemfontein, 9301, South Africa

Location

TREAD Research

Cape Town, 7500, South Africa

Location

TASK Central

Cape Town, 7530, South Africa

Location

Tiervlei Trial Centre

Cape Town, 7530, South Africa

Location

Synopsis Research

Cape Town, 7708, South Africa

Location

Synergy Biomed Research Institute (SBRI)

East London, 5201, South Africa

Location

Aliwal Shoal Medical Centre

eMkhomazi, 4170, South Africa

Location

Fola Health

Johannesburg, 2091, South Africa

Location

Trident Clinical

Kimberley, 8301, South Africa

Location

Ubuntu Clinical Research Krugersdorp

Krugersdorp, 1739, South Africa

Location

Drs H & V Makan Centre for Diabetes

Lenasia, 1827, South Africa

Location

Be Part Research (PTY) LTD

Paarl, 7626, South Africa

Location

Emmed Research

Pretoria, 0002, South Africa

Location

Dr JM Engelbrecht Trial Site

Somerset West, 7130, South Africa

Location

Sheikh Khalifa Medical City

Abu Dhabi, 51900, United Arab Emirates

Location

NMC Abu Dhabi

Abu Dhabi, 6222, United Arab Emirates

Location

Tawam Hospital

Al Ain City, 15258, United Arab Emirates

Location

Emirates Hospital Dubai

Dubai, 0000, United Arab Emirates

Location

Dubai Hospital

Dubai, 7272, United Arab Emirates

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior; Fasting

Interventions

orforglipron

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Behavior, Animal

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

IN (9); AE (5); ZA (14); SA (9)