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 College๐Ÿ‡ฎ๐Ÿ‡ณ Agra, India
Prabhat Kumar AgrawalPrincipal Investigator
Osmania General Hospital๐Ÿ‡ฎ๐Ÿ‡ณ Hyderabad, India
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Rakesh Kumar SahayPrincipal Investigator
Brij Medical Centre Pvt. Ltd.๐Ÿ‡ฎ๐Ÿ‡ณ Kanpur, India
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Brij MohanPrincipal Investigator
Apollo Multispeciality Hospitals limited๐Ÿ‡ฎ๐Ÿ‡ณ Kolkata, India
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Suvro BanerjeePrincipal Investigator
KGN Diabetes and Endocrinology Centre๐Ÿ‡ฎ๐Ÿ‡ณ Mumbai, India
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Shehla ShaikhPrincipal Investigator
Mysore Medical College and Research Institute๐Ÿ‡ฎ๐Ÿ‡ณ Mysore, India
Sumaiya AnjumPrincipal Investigator
Supe Heart & Diabetes Hospital & Research Centre๐Ÿ‡ฎ๐Ÿ‡ณ Nashik, India
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Pravin SupePrincipal Investigator
Diabetes Clinic๐Ÿ‡ฎ๐Ÿ‡ณ Nellore, India
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Satyanarayana MurthyPrincipal Investigator
Visakha Institute of Medical Sciences๐Ÿ‡ฎ๐Ÿ‡ณ Visakhapatna, India
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Baratam Hari KiranPrincipal Investigator
King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs๐ŸŒ Al-Ahsa, Saudi Arabia
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Maram AlsubaiePrincipal Investigator
Imam Abdulrahman Bin Faisal University๐ŸŒ Dammam, Saudi Arabia
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Maryam AlSoweilemPrincipal Investigator
King Fahad Specialist Hospital๐ŸŒ Dammam, Saudi Arabia
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Abdulwahab Al TurkiPrincipal Investigator
Dr. Soliman Fakeeh Hospital๐ŸŒ Jeddah, Saudi Arabia
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Faisal AljehaniPrincipal Investigator
King Abdulaziz University Hospital๐ŸŒ Jeddah, Saudi Arabia
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Hala MosliPrincipal Investigator
King Fahad Armed Forces Hospital Jeddah๐ŸŒ Jeddah, Saudi Arabia
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Samia BokhariPrincipal Investigator
National Guard Health Affairs: King Abdulaziz Medical City๐ŸŒ Jeddah, Saudi Arabia
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Hend AlzanabqiPrincipal Investigator
Dr. Soliman Fakeeh Hospital๐ŸŒ Riyadh, Saudi Arabia
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Ahmad AlobedollahPrincipal Investigator
King Saud University Medical City๐ŸŒ Riyadh, Saudi Arabia
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Khaled AburishehPrincipal Investigator
Osepdale Fatebenefratelli e Oftalmico๐ŸŒ Riyadh, Saudi Arabia
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Mohammed Al MehthelPrincipal Investigator
JOSHA Research๐Ÿ‡ฟ๐Ÿ‡ฆ Bloemfontein, South Africa
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Muddassir AhmedPrincipal Investigator
Synopsis Research๐Ÿ‡ฟ๐Ÿ‡ฆ Cape Town, South Africa
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Shaunagh EmanuelPrincipal Investigator
TASK Central๐Ÿ‡ฟ๐Ÿ‡ฆ Cape Town, South Africa
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Reinard McPhersonPrincipal Investigator
TREAD Research๐Ÿ‡ฟ๐Ÿ‡ฆ Cape Town, South Africa
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Anronel StofbergPrincipal Investigator
Tiervlei Trial Centre๐Ÿ‡ฟ๐Ÿ‡ฆ Cape Town, South Africa
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Zarinah MohamedPrincipal Investigator
Synergy Biomed Research Institute (SBRI)๐Ÿ‡ฟ๐Ÿ‡ฆ East London, South Africa
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Mookho MalahlehaPrincipal Investigator
Fola Health๐Ÿ‡ฟ๐Ÿ‡ฆ Johannesburg, South Africa
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Terisha NaidooPrincipal Investigator
Trident Clinical๐Ÿ‡ฟ๐Ÿ‡ฆ Kimberley, South Africa
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Lorato PataPrincipal Investigator
Ubuntu Clinical Research Krugersdorp๐Ÿ‡ฟ๐Ÿ‡ฆ Krugersdorp, South Africa
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Gertruida KrugerPrincipal Investigator
Drs H & V Makan Centre for Diabetes๐Ÿ‡ฟ๐Ÿ‡ฆ Lenasia, South Africa
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Hemant MakanPrincipal Investigator
Be Part Research (PTY) LTD๐Ÿ‡ฟ๐Ÿ‡ฆ Paarl, South Africa
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Chrisna AndersenPrincipal Investigator
Emmed Research๐Ÿ‡ฟ๐Ÿ‡ฆ Pretoria, South Africa
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Johannes BreedtPrincipal Investigator
Dr JM Engelbrecht Trial Site๐Ÿ‡ฟ๐Ÿ‡ฆ Somerset West, South Africa
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Johannes EngelbrechtPrincipal Investigator
Aliwal Shoal Medical Centre๐Ÿ‡ฟ๐Ÿ‡ฆ eMkhomazi, South Africa
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Trevenesan PadayacheePrincipal Investigator
Burjeel Medical City๐Ÿ‡ฆ๐Ÿ‡ช Abu Dhabi, United Arab Emirates
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Mohammad FityanPrincipal Investigator
NMC Abu Dhabi๐Ÿ‡ฆ๐Ÿ‡ช Abu Dhabi, United Arab Emirates
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Dinesh Kumar DhanwalPrincipal Investigator
NMC Royal hospital๐Ÿ‡ฆ๐Ÿ‡ช Abu Dhabi, United Arab Emirates
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Fahad MalikPrincipal Investigator
Sheikh Khalifa Medical City๐Ÿ‡ฆ๐Ÿ‡ช Abu Dhabi, United Arab Emirates
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Tarek FiadPrincipal Investigator
Tawam Hospital๐Ÿ‡ฆ๐Ÿ‡ช Al Ain City, United Arab Emirates
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Mohamed ElSabbaghPrincipal Investigator
Dubai Hospital๐Ÿ‡ฆ๐Ÿ‡ช Dubai, United Arab Emirates
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Fatheya Al AwadiPrincipal Investigator
Emirates Hospital Dubai๐Ÿ‡ฆ๐Ÿ‡ช Dubai, United Arab Emirates
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Jalal NafachPrincipal Investigator