Health Trials

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

ConditionsDiabetes 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
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Orforglipron

Treatment groups

130 Participants
are divided into 1 treatment group

Locations

37
India
Sarojini Naidu Medical College282003, Agra India
Osmania General Hospital500012, Hyderabad India
Brij Medical Centre Pvt. Ltd.208020, Kanpur India
Apollo Multispeciality Hospitals limited700054, Kolkata India

Sponsors and collaborators

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov