Behavior, Diabetes Melletus, Diabetes Mellitus, Type 2, Endocrine System Diseases, Fasting, Feeding Behavior, Glucagon-Like Peptide-1 Receptor, Glucagon-Like Peptide Receptors, Glucose Metabolism Disorders, Membrane Proteins, Metabolic Disorders, Nutritional and Metabolic Diseases, Proteins, Receptors, Cell Surface, Receptors, G-Protein-Coupled, Receptors, Peptide
Conditions
Keywords
Ramadan, Fasting
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.
Interventions
DRUGOrforglipron
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1C (HbA1c) | Baseline, up to 8 Weeks after Start of Ramadan |
Secondary
| Measure | Time frame |
|---|---|
| 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] |
| Percent Change in Body Weight | 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan] |
Countries
India, Saudi Arabia, South Africa, United Arab Emirates
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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
Outcome results
None listed