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

RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Diabetes Mellitus, Type 2, Diabetes Melletus, Glucose Metabolism Disorders, Metabolic Disorders, Nutritional and Metabolic Diseases

Interventions: Orforglipron

Countries: India, Saudi Arabia, South Africa, United Arab Emirates

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (40)

Agra, India
Hyderabad, India
Kanpur, India
Kolkata, India
Mumbai, India
Mysore, India
Nashik, India
Nellore, India
Visakhapatna, India
Al-Ahsa, Saudi Arabia
Dammam, Saudi Arabia
Dammam, Saudi Arabia
Jeddah, Saudi Arabia
Jeddah, Saudi Arabia
Jeddah, Saudi Arabia
Jeddah, Saudi Arabia
Riyadh, Saudi Arabia
Riyadh, Saudi Arabia
Riyadh, Saudi Arabia
Bloemfontein, South Africa
Cape Town, South Africa
Cape Town, South Africa
Cape Town, South Africa
Cape Town, South Africa
East London, South Africa
eMkhomazi, South Africa
Johannesburg, South Africa
Kimberley, South Africa
Krugersdorp, South Africa
Lenasia, South Africa
+ 10 more on CT.gov