NCT07613307 A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting
| NCT ID | NCT07613307 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Eli Lilly and Company |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-07-15 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 130 participants in total. It began in 2026-07-15 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
✉ LillyTrials@Lilly.com📞 1-317-615-4559
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)
STUDY DIRECTOR
Eli Lilly and Company
Frequently Asked Questions
Who can join the NCT07613307 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07613307 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 130 participants.
Is NCT07613307 currently recruiting?
Yes, NCT07613307 is actively recruiting participants. Contact the research team at LillyTrials@Lilly.com for enrollment information.
Where is the NCT07613307 trial being conducted?
This trial is being conducted at Agra, India, Hyderabad, India, Kanpur, India, Kolkata, India and 11 additional locations.
Who is sponsoring the NCT07613307 clinical trial?
NCT07613307 is sponsored by Eli Lilly and Company. The principal investigator is 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) at Eli Lilly and Company. The trial plans to enroll 130 participants.
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