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NCT Number: NCT07613307

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

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]

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Acronym: ACHIEVE-RAM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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