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

May 22, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • India
      • Agra, India, 282003
        • Sarojini Naidu Medical College
        • Contact:
          • Phone Number: +9156202361318 00000000000
        • Principal Investigator:
          • Prabhat Kumar Agrawal
      • Hyderabad, India, 500012
        • Osmania General Hospital
        • Principal Investigator:
          • Rakesh Kumar Sahay
        • Contact:
          • Phone Number: +914024600121 00 00000000
      • Kanpur, India, 208020
        • Brij Medical Centre Pvt. Ltd.
        • Principal Investigator:
          • Brij Mohan
        • Contact:
          • Phone Number: +915122262861 000 0000000
      • Kolkata, India, 700054
        • Apollo Multispeciality Hospitals Limited
        • Contact:
          • Phone Number: +913323203040 0000000000
        • Principal Investigator:
          • Suvro Banerjee
      • Mumbai, India, 400008
        • KGN Diabetes and Endocrinology Centre
        • Contact:
          • Phone Number: +912223021514 00 00000000
        • Principal Investigator:
          • Shehla Shaikh
      • Mysore, India, 570001
        • Mysore Medical College and Research Institute
        • Principal Investigator:
          • Sumaiya Anjum
        • Contact:
          • Phone Number: +9182102420142 00000000000
      • Nashik, India, 422002
        • Supe Heart & Diabetes Hospital & Research Centre
        • Principal Investigator:
          • Pravin Supe
        • Contact:
          • Phone Number: +912532232487 0000000000
      • Nellore, India, 524001
        • Diabetes Clinic
        • Contact:
          • Phone Number: +91009000991188
        • Principal Investigator:
          • Satyanarayana Murthy
      • Visakhapatna, India, 530040
        • Visakha Institute of Medical Sciences
        • Contact:
          • Phone Number: +917842685101 0000000000
        • Principal Investigator:
          • Baratam Hari Kiran
  • Saudi Arabia
      • Al-Ahsa, Saudi Arabia, 31982
        • King Abdulaziz University for Health Sciences Ministry of National Guard Health Affairs
        • Principal Investigator:
          • Maram Alsubaie
        • Contact:
          • Phone Number: +966555490155
      • Dammam, Saudi Arabia, 32253
        • King Fahad Specialist Hospital
        • Contact:
          • Phone Number: +966138442222
        • Principal Investigator:
          • Abdulwahab Al Turki
      • Jeddah, Saudi Arabia, 21461
        • Dr. Soliman Fakeeh Hospital
        • Contact:
          • Phone Number: +966920012777
        • Principal Investigator:
          • Faisal Aljehani
      • Jeddah, Saudi Arabia, 21423
        • National Guard Health Affairs: King Abdulaziz Medical City
        • Contact:
          • Phone Number: +966122266666
        • Principal Investigator:
          • Hend Alzanabqi
      • Jeddah, Saudi Arabia, 22254
        • King AbdulAziz University Hospital
        • Contact:
          • Phone Number: +9666408222
        • Principal Investigator:
          • Hala Mosli
      • Jeddah, Saudi Arabia, 23311
        • King Fahad Armed Forces Hospital Jeddah
        • Principal Investigator:
          • Samia Bokhari
        • Contact:
          • Phone Number: +966505402105
      • Riyadh, Saudi Arabia, 11472
        • King Saud University Medical City
        • Contact:
          • Phone Number: +966558006606
        • Principal Investigator:
          • Khaled Aburisheh
      • Riyadh, Saudi Arabia, 11564
        • Dr. Soliman Fakeeh Hospital
        • Contact:
          • Phone Number: +966920012777
        • Principal Investigator:
          • Ahmad Alobedollah
      • Riyadh, Saudi Arabia, 12231
        • Osepdale Fatebenefratelli e Oftalmico
        • Principal Investigator:
          • Mohammed Al Mehthel
        • Contact:
          • Phone Number: +966536448950
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Josha Research
        • Contact:
          • Phone Number: +27514128160
        • Principal Investigator:
          • Muddassir Ahmed
      • Cape Town, South Africa, 7530
        • TASK Central
        • Contact:
          • Phone Number: +27219171226
        • Principal Investigator:
          • Reinard McPherson
      • Cape Town, South Africa, 7500
        • TREAD Research
        • Contact:
          • Phone Number: +27219317825
        • Principal Investigator:
          • Anronel Stofberg
      • Cape Town, South Africa, 7530
        • Tiervlei Trial Centre
        • Principal Investigator:
          • Zarinah Mohamed
        • Contact:
          • Phone Number: +27219579400
      • Cape Town, South Africa, 7708
        • Synopsis Research
        • Principal Investigator:
          • Shaunagh Emanuel
        • Contact:
          • Phone Number: +27216716694
      • East London, South Africa, 5201
        • Synergy Biomed Research Institute (SBRI)
        • Principal Investigator:
          • Mookho Malahleha
        • Contact:
          • Phone Number: +27437222306
      • Johannesburg, South Africa, 2091
        • Fola Health
        • Contact:
          • Phone Number: +27119834270
        • Principal Investigator:
          • Terisha Naidoo
      • Kimberley, South Africa, 8301
        • Trident Clinical
        • Contact:
          • Phone Number: +27815480763
        • Principal Investigator:
          • Lorato Pata
      • Krugersdorp, South Africa, 1739
        • Ubuntu Clinical Research Krugersdorp
        • Contact:
          • Phone Number: +27827887649
        • Principal Investigator:
          • Gertruida Kruger
      • Lenasia, South Africa, 1827
        • Drs H & V Makan Centre for Diabetes
        • Principal Investigator:
          • Hemant Makan
        • Contact:
          • Phone Number: +27118524397
      • Paarl, South Africa, 7626
        • Be Part Research (PTY) LTD
        • Contact:
          • Phone Number: +27218683990
        • Principal Investigator:
          • Chrisna Andersen
      • Pretoria, South Africa, 0002
        • Emmed Research
        • Principal Investigator:
          • Johannes Breedt
        • Contact:
          • Phone Number: +27123436844
      • Somerset West, South Africa, 7130
        • Dr JM Engelbrecht Trial Site
        • Principal Investigator:
          • Johannes Engelbrecht
        • Contact:
          • Phone Number: +27218501016
      • eMkhomazi, South Africa, 4170
        • Aliwal Shoal Medical Centre
        • Principal Investigator:
          • Trevenesan Padayachee
        • Contact:
          • Phone Number: +27399732361
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 51900
        • Sheikh Khalifa Medical City
        • Contact:
          • Phone Number: +97128190000
        • Principal Investigator:
          • Tarek Fiad
      • Abu Dhabi, United Arab Emirates, 6222
        • NMC Abu Dhabi
        • Contact:
          • Phone Number: +971528916223
        • Principal Investigator:
          • Dinesh Kumar Dhanwal
      • Al Ain City, United Arab Emirates, 15258
        • Tawam Hospital
        • Contact:
          • Phone Number: +97137677444
        • Principal Investigator:
          • Mohamed ElSabbagh
      • Dubai, United Arab Emirates, 7272
        • Dubai Hospital
        • Principal Investigator:
          • Fatheya Al Awadi
        • Contact:
          • Phone Number: +97142195000
      • Dubai, United Arab Emirates, 0000
        • Emirates Hospital Dubai
        • Principal Investigator:
          • Jalal Nafach
        • Contact:
          • Phone Number: +971800444444

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 family (first-degree relative) or personal history of medullary thyroid carcinoma
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Orforglipron
Administered orally
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1C (HbA1c)
Time Frame: Baseline, up to 8 Weeks after Start of Ramadan
Baseline, up to 8 Weeks after Start of Ramadan

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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]
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]
4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27746
  • J2A-MC-GZPV (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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