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

RECRUITINGPhase 3Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 3
SponsorEli Lilly and Company
Started2026-07-15
Est. completion2027-05
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07613307

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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.

Conditions17

BehaviorDiabetesDiabetes MelletusDiabetes Mellitus, Type 2Endocrine System DiseasesFastingFeeding BehaviorGlucagon-Like Peptide ReceptorsGlucagon-Like Peptide-1 ReceptorGlucose Metabolism Disorders

Interventions1

Orforglipron

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