Orforglipron for Type 2 Diabetes in Ramadan Fasters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial will enroll adults with type 2 diabetes who plan to fast during Ramadan. Participants will receive orforglipron and be followed for up to 48 weeks, with at least seven in-clinic visits and four virtual visits. The study monitors safety and efficacy in the context of Ramadan fasting to see how the treatment affects glucose management during periods of intentional dietary change. Eligibility requires stable weight, a specific range of HbA1c, and a commitment to fasting. Exclusion criteria rule out other forms of diabetes and certain thyroid and pancreatic conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.