Diabetes Mellitus, Type 2Phase 3ACHIEVE-RAMNCT07613307
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting
A Phase 3 study testing Orforglipron in people with Diabetes Mellitus, Type 2 and Diabetes Melletus, run by Eli Lilly and Company at 40 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Melletus, Glucose Metabolism Disorders
- What is being tested?
- Orforglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 40 sitesin 4 countries
- Study dates
- 15 Jul 2026to May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
40 sites in 4 countries
South Africa14 sites, 14 recruiting
- Recruiting
JOSHA Research
Bloemfontein, 9301
+27514128160
Muddassir Ahmed
- Recruiting
TREAD Research
Cape Town, 7500
+27219317825
Terusha Navsaria
- Recruiting
TASK Central
Cape Town, 7530
+27219171226
Reinard McPherson
- Recruiting
Tiervlei Trial Centre
Cape Town, 7530
+27219579400
Zarinah Mohamed
- Recruiting
Synopsis Research
Cape Town, 7708
+27216716694
Shaunagh Emanuel
- Recruiting
Synergy Biomed Research Institute (SBRI)
East London, 5201
+27437222306
Mookho Malahleha
- Recruiting
Aliwal Shoal Medical Centre
eMkhomazi, 4170
+27399732361
Trevenesan Padayachee
- Recruiting
Fola Health
Johannesburg, 2091
+27119834270
Terisha Naidoo
- Recruiting
Trident Clinical
Kimberley, 8301
+27815480763
Lorato Pata
- Recruiting
Ubuntu Clinical Research Krugersdorp
Krugersdorp, 1739
+27827887649
Gertruida Kruger
- Recruiting
Drs H & V Makan Centre for Diabetes
Lenasia, 1827
+27118524397
Hemant Makan
- Recruiting
Be Part Research (PTY) LTD
Paarl, 7626
+27218683990
Chrisna Andersen
- Recruiting
Emmed Research
Pretoria, 0002
+27123436844
Johannes Breedt
- Recruiting
Dr JM Engelbrecht Trial Site
Somerset West, 7130
+27218501016
Johannes Engelbrecht
Saudi Arabia10 sites, 10 recruiting
- Not yet recruiting
King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs
Al-Ahsa, 31982
+966555490155
Maram Alsubaie
- Recruiting
King Fahad Specialist Hospital
Dammam, 32253
+966138442222
Abdulwahab Al Turki
- Recruiting
Imam Abdulrahman Bin Faisal University
Dammam, 34212
+966133333766
Maryam AlSoweilem
- Not yet recruiting
National Guard Health Affairs: King Abdulaziz Medical City
Jeddah, 21423
+966122266666
Hend Alzanabqi
- Recruiting
King Abdulaziz University Hospital
Jeddah, 22254
+9666408222
Hala Mosli
- Not yet recruiting
King Fahad Armed Forces Hospital Jeddah
Jeddah, 23311
+966505402105
Samia Bokhari
- Recruiting
Dr. Soliman Fakeeh Hospital
Jeddah, 23331
+966920012777
Faisal Aljehani
- Recruiting
King Saud University Medical City
Riyadh, 11472
+966558006606
Khaled Aburisheh
- Not yet recruiting
Dr. Soliman Fakeeh Hospital
Riyadh, 11564
+966920012777
Ahmad Alobedollah
- Not yet recruiting
Osepdale Fatebenefratelli e Oftalmico
Riyadh, 12231
+966536448950
Mohammed Al Mehthel
India9 sites, 9 recruiting
- Recruiting
Sarojini Naidu Medical College
Agra, 282003
+9156202361318 00000000000
Prabhat Kumar Agrawal
- Recruiting
Osmania General Hospital
Hyderabad, 500012
+914024600121 00 00000000
Rakesh Kumar Sahay
- Recruiting
Brij Medical Centre Pvt. Ltd.
Kanpur, 208020
+915122262861 000 0000000
Brij Mohan
- Recruiting
Apollo Multispeciality Hospitals limited
Kolkata, 700054
+913323203040 0000000000
Suvro Banerjee
- Recruiting
KGN Diabetes and Endocrinology Centre
Mumbai, 400008
+912223021514 00 00000000
Shehla Shaikh
- Recruiting
Mysore Medical College and Research Institute
Mysore, 570001
+9182102420142 00000000000
Sumaiya Anjum
- Recruiting
Supe Heart & Diabetes Hospital & Research Centre
Nashik, 422002
+912532232487 0000000000
Pravin Supe
- Recruiting
Diabetes Clinic
Nellore, 524001
+91009000991188
Satyanarayana Murthy
- Recruiting
Visakha Institute of Medical Sciences
Visakhapatna, 530040
+917842685101 0000000000
Baratam Hari Kiran
United Arab Emirates7 sites, 7 recruiting
- Not yet recruiting
Burjeel Medical City
Abu Dhabi, 00000
+971505610503
Mohammad Fityan
- Recruiting
NMC Royal hospital
Abu Dhabi, 00000
+971504645539
Fahad Malik
- Recruiting
Sheikh Khalifa Medical City
Abu Dhabi, 0000
+97128190000
Tarek Fiad
- Recruiting
NMC Abu Dhabi
Abu Dhabi, 6222
+971528916223
Dinesh Kumar Dhanwal
- Recruiting
Tawam Hospital
Al Ain City, 15258
+97137677444
Mohamed ElSabbagh
- Not yet recruiting
Emirates Hospital Dubai
Dubai, 0000
+971800444444
Jalal Nafach
- Recruiting
Dubai Hospital
Dubai, 7272
+97142195000
Fatheya Al Awadi
About this study
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)
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.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Melletus, Glucose Metabolism Disorders, Metabolic Disorders, Nutritional and Metabolic Diseases, Endocrine System Diseases
- Being tested
- Orforglipron
- Keywords
- Ramadan, Fasting
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Nutritional and Metabolic Diseases, Endocrine System Diseases, Feeding Behavior, Behavior, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrforglipronDrug
Also called LY3502970
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Orforglipron | Experimental | Administered orally Receives: Drug: Orforglipron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hemoglobin A1C (HbA1c)
Measured: Baseline, up to 8 Weeks after Start of Ramadan
Secondary outcomes (6)
Percentage of Participants with an HbA1c of less than (<) 7 Percent (%) (53 millimeters per mole (mmol/mol))
Measured: Baseline, Up to 8 Weeks after Start of Ramadan
Change From Baseline in Fasting Serum Glucose (FSG)
Measured: Baseline, Up to 8 Weeks after Start of Ramadan
Percent Change from Baseline in Body Weight
Measured: Baseline, Up to 8 Weeks after Start of Ramadan
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index
Measured: Baseline, Up to 8 Weeks after Start of Ramadan
Percent Change in HbA1c
Measured: 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]
Percent Change in Body Weight
Measured: 4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 Jul 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613307
- Sponsor's protocol ID
- 27746
- Other IDs
- J2A-MC-GZPV
- Acronym
- ACHIEVE-RAM
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07613307
- Acronym / sponsor ID
- ACHIEVE-RAM / 27746
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Melletus, Glucose Metabolism Disorders, Metabolic Disorders, Nutritional and Metabolic Diseases, Endocrine System Diseases
- Keywords
- Ramadan, Fasting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orforglipron | Experimental | Drug: OrforglipronAdministered orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrforglipronAlso: LY3502970Administered orally | Drug | Orforglipron |
Primary outcome
Change from Baseline in Hemoglobin A1C (HbA1c)
Time frame: Baseline, up to 8 Weeks after Start of Ramadan
6 secondary outcomes
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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
40 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orforglipron in people with Diabetes Mellitus, Type 2 and Diabetes Melletus, run by Eli Lilly and Company at 40 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in South Africa, Saudi Arabia, India, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Hemoglobin A1C (HbA1c) (time frame: Baseline, up to 8 Weeks after Start of Ramadan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.