ClinicalTrials.gg
RecruitingNCT07613307ACHIEVE-RAMUpdated Oct 8, 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 2026-10-08.

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

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
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

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 130 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.
  • Have an 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 (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 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 or are in remission from a malignancy for less than 5 years.
  • Have a history of cholecystectomy (surgically removed gallbladder)
  • Have Functional Classification IV congestive heart-failure.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

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

06

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]

07

Study locations

33 of 40 sites recruiting
  • Sarojini Naidu Medical College
    Agra, 282003, India
    Recruiting
    • · Contact+9156202361318 00000000000
    • Prabhat Kumar Agrawal · Principal investigator
  • Osmania General Hospital
    Hyderabad, 500012, India
    Recruiting
    • · Contact+914024600121 00 00000000
    • Rakesh Kumar Sahay · Principal investigator
  • Brij Medical Centre Pvt. Ltd.
    Kanpur, 208020, India
    Recruiting
    • · Contact+915122262861 000 0000000
    • Brij Mohan · Principal investigator
  • Apollo Multispeciality Hospitals limited
    Kolkata, 700054, India
    Recruiting
    • · Contact+913323203040 0000000000
    • Suvro Banerjee · Principal investigator
  • KGN Diabetes and Endocrinology Centre
    Mumbai, 400008, India
    Recruiting
    • · Contact+912223021514 00 00000000
    • Shehla Shaikh · Principal investigator
  • Mysore Medical College and Research Institute
    Mysore, 570001, India
    Recruiting
    • · Contact+9182102420142 00000000000
    • Sumaiya Anjum · Principal investigator
  • Supe Heart & Diabetes Hospital & Research Centre
    Nashik, 422002, India
    Recruiting
    • · Contact+912532232487 0000000000
    • Pravin Supe · Principal investigator
  • Diabetes Clinic
    Nellore, 524001, India
    Recruiting
    • · Contact+91009000991188
    • Satyanarayana Murthy · Principal investigator
  • Visakha Institute of Medical Sciences
    Visakhapatna, 530040, India
    Recruiting
    • · Contact+917842685101 0000000000
    • Baratam Hari Kiran · Principal investigator
  • King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs
    Al-Ahsa, 31982, Saudi Arabia
    Not yet recruiting
    • · Contact+966555490155
    • Maram Alsubaie · Principal investigator
  • King Fahad Specialist Hospital
    Dammam, 32253, Saudi Arabia
    Recruiting
    • · Contact+966138442222
    • Abdulwahab Al Turki · Principal investigator
  • Imam Abdulrahman Bin Faisal University
    Dammam, 34212, Saudi Arabia
    Recruiting
    • · Contact+966133333766
    • Maryam AlSoweilem · Principal investigator
  • National Guard Health Affairs: King Abdulaziz Medical City
    Jeddah, 21423, Saudi Arabia
    Not yet recruiting
    • · Contact+966122266666
    • Hend Alzanabqi · Principal investigator
  • King Abdulaziz University Hospital
    Jeddah, 22254, Saudi Arabia
    Recruiting
    • · Contact+9666408222
    • Hala Mosli · Principal investigator
  • King Fahad Armed Forces Hospital Jeddah
    Jeddah, 23311, Saudi Arabia
    Not yet recruiting
    • · Contact+966505402105
    • Samia Bokhari · Principal investigator
  • Dr. Soliman Fakeeh Hospital
    Jeddah, 23331, Saudi Arabia
    Recruiting
    • · Contact+966920012777
    • Faisal Aljehani · Principal investigator
  • King Saud University Medical City
    Riyadh, 11472, Saudi Arabia
    Recruiting
    • · Contact+966558006606
    • Khaled Aburisheh · Principal investigator
  • Dr. Soliman Fakeeh Hospital
    Riyadh, 11564, Saudi Arabia
    Not yet recruiting
    • · Contact+966920012777
    • Ahmad Alobedollah · Principal investigator
  • Osepdale Fatebenefratelli e Oftalmico
    Riyadh, 12231, Saudi Arabia
    Not yet recruiting
    • · Contact+966536448950
    • Mohammed Al Mehthel · Principal investigator
  • JOSHA Research
    Bloemfontein, 9301, South Africa
    Recruiting
    • · Contact+27514128160
    • Muddassir Ahmed · Principal investigator
  • TREAD Research
    Cape Town, 7500, South Africa
    Recruiting
    • · Contact+27219317825
    • Terusha Navsaria · Principal investigator
  • TASK Central
    Cape Town, 7530, South Africa
    Recruiting
    • · Contact+27219171226
    • Reinard McPherson · Principal investigator
  • Tiervlei Trial Centre
    Cape Town, 7530, South Africa
    Recruiting
    • · Contact+27219579400
    • Zarinah Mohamed · Principal investigator
  • Synopsis Research
    Cape Town, 7708, South Africa
    Recruiting
    • · Contact+27216716694
    • Shaunagh Emanuel · Principal investigator
  • Synergy Biomed Research Institute (SBRI)
    East London, 5201, South Africa
    Recruiting
    • · Contact+27437222306
    • Mookho Malahleha · Principal investigator
  • Aliwal Shoal Medical Centre
    eMkhomazi, 4170, South Africa
    Recruiting
    • · Contact+27399732361
    • Trevenesan Padayachee · Principal investigator
  • Fola Health
    Johannesburg, 2091, South Africa
    Recruiting
    • · Contact+27119834270
    • Terisha Naidoo · Principal investigator
  • Trident Clinical
    Kimberley, 8301, South Africa
    Recruiting
    • · Contact+27815480763
    • Lorato Pata · Principal investigator
  • Ubuntu Clinical Research Krugersdorp
    Krugersdorp, 1739, South Africa
    Recruiting
    • · Contact+27827887649
    • Gertruida Kruger · Principal investigator
  • Drs H & V Makan Centre for Diabetes
    Lenasia, 1827, South Africa
    Recruiting
    • · Contact+27118524397
    • Hemant Makan · Principal investigator
  • Be Part Research (PTY) LTD
    Paarl, 7626, South Africa
    Recruiting
    • · Contact+27218683990
    • Chrisna Andersen · Principal investigator
  • Emmed Research
    Pretoria, 0002, South Africa
    Recruiting
    • · Contact+27123436844
    • Johannes Breedt · Principal investigator
  • Dr JM Engelbrecht Trial Site
    Somerset West, 7130, South Africa
    Recruiting
    • · Contact+27218501016
    • Johannes Engelbrecht · Principal investigator
  • Burjeel Medical City
    Abu Dhabi, 00000, United Arab Emirates
    Not yet recruiting
    • · Contact+971505610503
    • Mohammad Fityan · Principal investigator
  • NMC Royal hospital
    Abu Dhabi, 00000, United Arab Emirates
    Recruiting
    • · Contact+971504645539
    • Fahad Malik · Principal investigator
  • Sheikh Khalifa Medical City
    Abu Dhabi, 0000, United Arab Emirates
    Recruiting
    • · Contact+97128190000
    • Tarek Fiad · Principal investigator
  • NMC Abu Dhabi
    Abu Dhabi, 6222, United Arab Emirates
    Recruiting
    • · Contact+971528916223
    • Dinesh Kumar Dhanwal · Principal investigator
  • Tawam Hospital
    Al Ain City, 15258, United Arab Emirates
    Recruiting
    • · Contact+97137677444
    • Mohamed ElSabbagh · Principal investigator
  • Emirates Hospital Dubai
    Dubai, 0000, United Arab Emirates
    Not yet recruiting
    • · Contact+971800444444
    • Jalal Nafach · Principal investigator
  • Dubai Hospital
    Dubai, 7272, United Arab Emirates
    Recruiting
    • · Contact+97142195000
    • Fatheya Al Awadi · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • TREAD Research · Cape Town, South AfricaContact person changed (no phone or email listed)
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • TREAD Research · Cape Town, South AfricaContact person changed (no phone or email listed)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07613307
Responsible party
Sponsor
First posted
May 29, 2026
Start date
Jul 15, 2026
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Oct 8, 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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