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Not yet recruiting NCT07613307

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

Phase III Interventional Diabetes Mellitus, Type 2 Diabetes Melletus Glucose Metabolism Disorders Metabolic Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Orforglipron.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2, Diabetes Melletus, Glucose Metabolism Disorders, Metabolic Disorders. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India, Saudi Arabia, South Africa, United Arab Emirates
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3b, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Orforglipron in Adult Participants With Type 2 Diabetes Who Observe Ramadan Fasting (ACHIEVE-RAM)

Overview

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

  • Drug Orforglipron
    Administered orally

Primary outcome measures

  • Change from Baseline in Hemoglobin A1C (HbA1c) [Time frame: Baseline, up to 8 Weeks after Start of Ramadan]
Secondary outcome measures (6)
  • Percentage of Participants with an HbA1c of less than (<) 7 Percent (%) (53 millimeters per mole (mmol/mol)) [Time frame: Baseline, Up to 8 Weeks after Start of Ramadan]
  • Change From Baseline in Fasting Serum Glucose (FSG) [Time frame: Baseline, Up to 8 Weeks after Start of Ramadan]
  • Percent Change from Baseline in Body Weight [Time frame: Baseline, Up to 8 Weeks after Start of Ramadan]
  • Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index [Time frame: Baseline, Up to 8 Weeks after Start of Ramadan]
  • Percent Change in HbA1c [Time frame: 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]]
  • Percent Change in Body Weight [Time frame: 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Africa · 14 centers
  • JOSHA Research — Bloemfontein
  • TREAD Research — Cape Town
  • TASK Central — Cape Town
  • Tiervlei Trial Centre — Cape Town
  • Synopsis Research — Cape Town
  • Synergy Biomed Research Institute (SBRI) — East London
  • Aliwal Shoal Medical Centre — eMkhomazi
  • Fola Health — Johannesburg
  • … and 6 more centers
India · 9 centers
  • Sarojini Naidu Medical College — Agra
  • Osmania General Hospital — Hyderabad
  • Brij Medical Centre Pvt. Ltd. — Kanpur
  • Apollo Multispeciality Hospitals limited — Kolkata
  • KGN Diabetes and Endocrinology Centre — Mumbai
  • Mysore Medical College and Research Institute — Mysore
  • Supe Heart & Diabetes Hospital & Research Centre — Nashik
  • Diabetes Clinic — Nellore
  • … and 1 more center
Saudi Arabia · 9 centers
  • King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs — Al-Ahsa
  • King Fahad Specialist Hospital — Dammam
  • National Guard Health Affairs: King Abdulaziz Medical City — Jeddah
  • Dr. Soliman Fakeeh Hospital — Jeddah
  • King Abdulaziz University Hospital — Jeddah
  • King Fahad Armed Forces Hospital Jeddah — Jeddah
  • King Saud University Medical City — Riyadh
  • Dr. Soliman Fakeeh Hospital — Riyadh
  • … and 1 more center
United Arab Emirates · 5 centers
  • Sheikh Khalifa Medical City — Abu Dhabi
  • NMC Abu Dhabi — Abu Dhabi
  • Tawam Hospital — Al Ain City
  • Emirates Hospital Dubai — Dubai
  • Dubai Hospital — Dubai

Identifiers

NCT: NCT07613307 · 27746 · J2A-MC-GZPV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗