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RecruitingNCT07613307ACHIEVE-RAMUpdated Sep 22, 2026

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

A Phase 3 interventional study of Orforglipron in Diabetes Mellitus, Type 2, Diabetes Melletus and Glucose Metabolism Disorders, sponsored by Eli Lilly and Company. Recruiting at 40 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
130
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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

Keywords

  • Ramadan
  • Fasting
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Orforglipron

    Administered orally

    Drug: Orforglipron

Interventions

  • DrugOrforglipron

    Administered orally

    Also known as: LY3502970

05

What researchers measure

Primary outcomes

  1. Change from Baseline in Hemoglobin A1C (HbA1c)

    Time frame: Baseline, up to 8 Weeks after Start of Ramadan

Secondary outcomes

  1. 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

  2. Change From Baseline in Fasting Serum Glucose (FSG)

    Time frame: Baseline, Up to 8 Weeks after Start of Ramadan

  3. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Up to 8 Weeks after Start of Ramadan

  4. Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index

    Time frame: Baseline, Up to 8 Weeks after Start of Ramadan

  5. Percent Change in HbA1c

    Time frame: 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]

  6. Percent Change in Body Weight

    Time frame: 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]

06

Study locations

33 of 40 sites recruiting
  • Sarojini Naidu Medical College
    Agra, 282003, India
    • · Contact · +9156202361318 00000000000
    • Prabhat Kumar Agrawal · Principal investigator
    Recruiting
  • Osmania General Hospital
    Hyderabad, 500012, India
    • · Contact · +914024600121 00 00000000
    • Rakesh Kumar Sahay · Principal investigator
    Recruiting
  • Brij Medical Centre Pvt. Ltd.
    Kanpur, 208020, India
    • · Contact · +915122262861 000 0000000
    • Brij Mohan · Principal investigator
    Recruiting
  • Apollo Multispeciality Hospitals limited
    Kolkata, 700054, India
    • · Contact · +913323203040 0000000000
    • Suvro Banerjee · Principal investigator
    Recruiting
  • KGN Diabetes and Endocrinology Centre
    Mumbai, 400008, India
    • · Contact · +912223021514 00 00000000
    • Shehla Shaikh · Principal investigator
    Recruiting
  • Mysore Medical College and Research Institute
    Mysore, 570001, India
    • · Contact · +9182102420142 00000000000
    • Sumaiya Anjum · Principal investigator
    Recruiting
  • Supe Heart & Diabetes Hospital & Research Centre
    Nashik, 422002, India
    • · Contact · +912532232487 0000000000
    • Pravin Supe · Principal investigator
    Recruiting
  • Diabetes Clinic
    Nellore, 524001, India
    • · Contact · +91009000991188
    • Satyanarayana Murthy · Principal investigator
    Recruiting
  • Visakha Institute of Medical Sciences
    Visakhapatna, 530040, India
    • · Contact · +917842685101 0000000000
    • Baratam Hari Kiran · Principal investigator
    Recruiting
  • King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs
    Al-Ahsa, 31982, Saudi Arabia
    • · Contact · +966555490155
    • Maram Alsubaie · Principal investigator
    Not yet recruiting
  • King Fahad Specialist Hospital
    Dammam, 32253, Saudi Arabia
    • · Contact · +966138442222
    • Abdulwahab Al Turki · Principal investigator
    Recruiting
  • Imam Abdulrahman Bin Faisal University
    Dammam, 34212, Saudi Arabia
    • · Contact · +966133333766
    • Maryam AlSoweilem · Principal investigator
    Recruiting
  • National Guard Health Affairs: King Abdulaziz Medical City
    Jeddah, 21423, Saudi Arabia
    • · Contact · +966122266666
    • Hend Alzanabqi · Principal investigator
    Not yet recruiting
  • King Abdulaziz University Hospital
    Jeddah, 22254, Saudi Arabia
    • · Contact · +9666408222
    • Hala Mosli · Principal investigator
    Recruiting
  • King Fahad Armed Forces Hospital Jeddah
    Jeddah, 23311, Saudi Arabia
    • · Contact · +966505402105
    • Samia Bokhari · Principal investigator
    Not yet recruiting
  • Dr. Soliman Fakeeh Hospital
    Jeddah, 23331, Saudi Arabia
    • · Contact · +966920012777
    • Faisal Aljehani · Principal investigator
    Recruiting
  • King Saud University Medical City
    Riyadh, 11472, Saudi Arabia
    • · Contact · +966558006606
    • Khaled Aburisheh · Principal investigator
    Recruiting
  • Dr. Soliman Fakeeh Hospital
    Riyadh, 11564, Saudi Arabia
    • · Contact · +966920012777
    • Ahmad Alobedollah · Principal investigator
    Not yet recruiting
  • Osepdale Fatebenefratelli e Oftalmico
    Riyadh, 12231, Saudi Arabia
    • · Contact · +966536448950
    • Mohammed Al Mehthel · Principal investigator
    Not yet recruiting
  • JOSHA Research
    Bloemfontein, 9301, South Africa
    • · Contact · +27514128160
    • Muddassir Ahmed · Principal investigator
    Recruiting
  • TREAD Research
    Cape Town, 7500, South Africa
    • · Contact · +27219317825
    • Anronel Stofberg · Principal investigator
    Recruiting
  • TASK Central
    Cape Town, 7530, South Africa
    • · Contact · +27219171226
    • Reinard McPherson · Principal investigator
    Recruiting
  • Tiervlei Trial Centre
    Cape Town, 7530, South Africa
    • · Contact · +27219579400
    • Zarinah Mohamed · Principal investigator
    Recruiting
  • Synopsis Research
    Cape Town, 7708, South Africa
    • · Contact · +27216716694
    • Shaunagh Emanuel · Principal investigator
    Recruiting
  • Synergy Biomed Research Institute (SBRI)
    East London, 5201, South Africa
    • · Contact · +27437222306
    • Mookho Malahleha · Principal investigator
    Recruiting
  • Aliwal Shoal Medical Centre
    eMkhomazi, 4170, South Africa
    • · Contact · +27399732361
    • Trevenesan Padayachee · Principal investigator
    Recruiting
  • Fola Health
    Johannesburg, 2091, South Africa
    • · Contact · +27119834270
    • Terisha Naidoo · Principal investigator
    Recruiting
  • Trident Clinical
    Kimberley, 8301, South Africa
    • · Contact · +27815480763
    • Lorato Pata · Principal investigator
    Recruiting
  • Ubuntu Clinical Research Krugersdorp
    Krugersdorp, 1739, South Africa
    • · Contact · +27827887649
    • Gertruida Kruger · Principal investigator
    Recruiting
  • Drs H & V Makan Centre for Diabetes
    Lenasia, 1827, South Africa
    • · Contact · +27118524397
    • Hemant Makan · Principal investigator
    Recruiting
  • Be Part Research (PTY) LTD
    Paarl, 7626, South Africa
    • · Contact · +27218683990
    • Chrisna Andersen · Principal investigator
    Recruiting
  • Emmed Research
    Pretoria, 0002, South Africa
    • · Contact · +27123436844
    • Johannes Breedt · Principal investigator
    Recruiting
  • Dr JM Engelbrecht Trial Site
    Somerset West, 7130, South Africa
    • · Contact · +27218501016
    • Johannes Engelbrecht · Principal investigator
    Recruiting
  • Burjeel Medical City
    Abu Dhabi, 00000, United Arab Emirates
    • · Contact · +971505610503
    • Mohammad Fityan · Principal investigator
    Not yet recruiting
  • NMC Royal hospital
    Abu Dhabi, 00000, United Arab Emirates
    • · Contact · +971504645539
    • Fahad Malik · Principal investigator
    Recruiting
  • Sheikh Khalifa Medical City
    Abu Dhabi, 0000, United Arab Emirates
    • · Contact · +97128190000
    • Tarek Fiad · Principal investigator
    Recruiting
  • NMC Abu Dhabi
    Abu Dhabi, 6222, United Arab Emirates
    • · Contact · +971528916223
    • Dinesh Kumar Dhanwal · Principal investigator
    Recruiting
  • Tawam Hospital
    Al Ain City, 15258, United Arab Emirates
    • · Contact · +97137677444
    • Mohamed ElSabbagh · Principal investigator
    Recruiting
  • Emirates Hospital Dubai
    Dubai, 0000, United Arab Emirates
    • · Contact · +971800444444
    • Jalal Nafach · Principal investigator
    Not yet recruiting
  • Dubai Hospital
    Dubai, 7272, United Arab Emirates
    • · Contact · +97142195000
    • Fatheya Al Awadi · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07613307
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
May 29, 2026
Start date
Jul 15, 2026
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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