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NCT07613307
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting
Conditions: Diabetes Mellitus, Type 2, Diabetes Melletus, Glucose Metabolism Disorders, Metabolic Disorders, Nutritional and Metabolic Diseases, Endocrine System Diseases, Feeding Behavior, Behavior, Fasting, Glucagon-Like Peptide-1 Receptor, Glucagon-Like Peptide Receptors, Receptors, G-Protein-Coupled, Receptors, Cell Surface, Membrane Proteins, Proteins, Receptors, Peptide
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 130
Sponsor: Eli Lilly and Company
Location: Sarojini Naidu Medical College Agra
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.
Source: ClinicalTrials.gov (NCT07613307). StuddyBuddy aggregates publicly available trial information.