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Trial · Interventional

RecruitingPhase 3Registry data

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

Short name ACHIEVE-RAM

NCTNCT07613307 (opens ClinicalTrials.gov in a new tab)Other id27746Other idJ2A-MC-GZPV

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
130 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
4 countries

India, Saudi Arabia, South Africa, United Arab Emirates

Start
15 Jul 2026
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
First posted
29 May 2026
Last update posted
8 Oct 2026
Conditions
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

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 3

    ACHIEVE-RAM

    NCT07613307

    15 Jul 2026 to est. May 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OrforglipronDrug

Arms1

  • Experimental

    Orforglipron

    Administered orally

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from Baseline in Hemoglobin A1C (HbA1c)

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

Secondary outcomes(6)
  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]

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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