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Completed

NCT Number: NCT06635057

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan

The main purpose of the study is to investigate whether tirzepatide can be effectively started before Ramadan and used per label in participants with Type 2 Diabetes during the fasting month.

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Key information

Conditions

Type 2 Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Al Moosa Specialist Hospital, Al Ahasa, Saudi Arabia

Loading trial locations.

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 uncontrolled Type 2 Diabetes based on the World Health Organization classification or other locally applicable diagnostic standards, and who intend to fast during Ramadan
  • Have HbA1c ≥7% within 30 days prior to screening
  • Are glucagon-like peptide-1 receptor agonist (GLP-1 RA) naïve
  • Have had stable body weight self-reported change ≤5 kilograms (kg) during the 90 days prior to screening
  • Have body mass index ≥25 kilograms per square meter (kg/m2) at screening

Exclusion criteria

  • Have Type 1 Diabetes or gestational diabetes
  • Have a history of chronic or acute pancreatitis
  • Have acute or chronic hepatitis
  • Have evidence of a significant, uncontrolled endocrine abnormality
  • Have a history of an active or untreated malignancy
  • Have New York Heart Association Functional Classification IV congestive heart failure
  • Have been treated with insulin within two weeks prior to screening

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Primary outcomes

  1. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)

Secondary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR

  2. Number of Hypoglycemic Events

    Time frame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR

  3. Number of Self-Reported Gastrointestinal (GI) Adverse Events

    Time frame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR

  4. Percentage of Participants Achieving HbA1c <7%

    Time frame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR

  5. Change from SoR to End of Ramadan (EoR) in the 5-Level European Quality of Life 5 Dimensions (EQ-5D-5L)

    Time frame: SoR (Week 0), EoR (Week 4)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 4, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Effectiveness and Safety of Tirzepatide Once Weekly in Adult Participants With Type 2 Diabetes During Ramadan

Acronym: T-RAM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2024
Registry last updated
May 22, 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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