Clinical trial
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting
Recruiting now ยท Phase 3 ยท 4 countries ยท Registry ID NCT07613307
Recruiting nowPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionDiabetes 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
Full registry 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.
Treatments and study arms
Orforglipron
Drug
Administered orally
Primary outcomes
Change from Baseline in Hemoglobin A1C (HbA1c)Baseline, up to 8 Weeks after Start of Ramadan
Study locations
40 locations were listed when this page was built. The first 40 are shown.
Sarojini Naidu Medical College๐ฎ๐ณ Agra, India
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Prabhat Kumar AgrawalPrincipal Investigator
Osmania General Hospital๐ฎ๐ณ Hyderabad, India
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Rakesh Kumar SahayPrincipal Investigator
Brij Medical Centre Pvt. Ltd.๐ฎ๐ณ Kanpur, India
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Brij MohanPrincipal Investigator
Apollo Multispeciality Hospitals limited๐ฎ๐ณ Kolkata, India
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Suvro BanerjeePrincipal Investigator
KGN Diabetes and Endocrinology Centre๐ฎ๐ณ Mumbai, India
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Shehla ShaikhPrincipal Investigator
Mysore Medical College and Research Institute๐ฎ๐ณ Mysore, India
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Sumaiya AnjumPrincipal Investigator
Supe Heart & Diabetes Hospital & Research Centre๐ฎ๐ณ Nashik, India
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Pravin SupePrincipal Investigator
Diabetes Clinic๐ฎ๐ณ Nellore, India
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Satyanarayana MurthyPrincipal Investigator
Visakha Institute of Medical Sciences๐ฎ๐ณ Visakhapatna, India
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Baratam Hari KiranPrincipal Investigator
King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs๐ Al-Ahsa, Saudi Arabia
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Maram AlsubaiePrincipal Investigator
Imam Abdulrahman Bin Faisal University๐ Dammam, Saudi Arabia
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Maryam AlSoweilemPrincipal Investigator
King Fahad Specialist Hospital๐ Dammam, Saudi Arabia
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Abdulwahab Al TurkiPrincipal Investigator
Dr. Soliman Fakeeh Hospital๐ Jeddah, Saudi Arabia
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Faisal AljehaniPrincipal Investigator
King Abdulaziz University Hospital๐ Jeddah, Saudi Arabia
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Hala MosliPrincipal Investigator
King Fahad Armed Forces Hospital Jeddah๐ Jeddah, Saudi Arabia
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Samia BokhariPrincipal Investigator
National Guard Health Affairs: King Abdulaziz Medical City๐ Jeddah, Saudi Arabia
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Hend AlzanabqiPrincipal Investigator
Dr. Soliman Fakeeh Hospital๐ Riyadh, Saudi Arabia
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Ahmad AlobedollahPrincipal Investigator
King Saud University Medical City๐ Riyadh, Saudi Arabia
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Khaled AburishehPrincipal Investigator
Osepdale Fatebenefratelli e Oftalmico๐ Riyadh, Saudi Arabia
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Mohammed Al MehthelPrincipal Investigator
JOSHA Research๐ฟ๐ฆ Bloemfontein, South Africa
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Muddassir AhmedPrincipal Investigator
Synopsis Research๐ฟ๐ฆ Cape Town, South Africa
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Shaunagh EmanuelPrincipal Investigator
TASK Central๐ฟ๐ฆ Cape Town, South Africa
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Reinard McPhersonPrincipal Investigator
TREAD Research๐ฟ๐ฆ Cape Town, South Africa
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Anronel StofbergPrincipal Investigator
Tiervlei Trial Centre๐ฟ๐ฆ Cape Town, South Africa
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Zarinah MohamedPrincipal Investigator
Synergy Biomed Research Institute (SBRI)๐ฟ๐ฆ East London, South Africa
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Mookho MalahlehaPrincipal Investigator
Fola Health๐ฟ๐ฆ Johannesburg, South Africa
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Terisha NaidooPrincipal Investigator
Trident Clinical๐ฟ๐ฆ Kimberley, South Africa
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Lorato PataPrincipal Investigator
Ubuntu Clinical Research Krugersdorp๐ฟ๐ฆ Krugersdorp, South Africa
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Gertruida KrugerPrincipal Investigator
Drs H & V Makan Centre for Diabetes๐ฟ๐ฆ Lenasia, South Africa
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Hemant MakanPrincipal Investigator
Be Part Research (PTY) LTD๐ฟ๐ฆ Paarl, South Africa
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Chrisna AndersenPrincipal Investigator
Emmed Research๐ฟ๐ฆ Pretoria, South Africa
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Johannes BreedtPrincipal Investigator
Dr JM Engelbrecht Trial Site๐ฟ๐ฆ Somerset West, South Africa
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Johannes EngelbrechtPrincipal Investigator
Aliwal Shoal Medical Centre๐ฟ๐ฆ eMkhomazi, South Africa
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Trevenesan PadayacheePrincipal Investigator
Burjeel Medical City๐ฆ๐ช Abu Dhabi, United Arab Emirates
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Mohammad FityanPrincipal Investigator
NMC Abu Dhabi๐ฆ๐ช Abu Dhabi, United Arab Emirates
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Dinesh Kumar DhanwalPrincipal Investigator
NMC Royal hospital๐ฆ๐ช Abu Dhabi, United Arab Emirates
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Fahad MalikPrincipal Investigator
Sheikh Khalifa Medical City๐ฆ๐ช Abu Dhabi, United Arab Emirates
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Tarek FiadPrincipal Investigator
Tawam Hospital๐ฆ๐ช Al Ain City, United Arab Emirates
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Mohamed ElSabbaghPrincipal Investigator
Dubai Hospital๐ฆ๐ช Dubai, United Arab Emirates
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Fatheya Al AwadiPrincipal Investigator
Emirates Hospital Dubai๐ฆ๐ช Dubai, United Arab Emirates
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Jalal NafachPrincipal Investigator