Clinical trial NCT06635057: A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes During Ramadan
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Ramadan
Fasting
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from Start of Ramadan (SoR)
Secondary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
measure: Number of Hypoglycemic Events
timeFrame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
measure: Number of Self-Reported Gastrointestinal (GI) Adverse Events
timeFrame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
measure: Percentage of Participants Achieving HbA1c <7%
timeFrame: Baseline (20 to 8 weeks Before Ramadan), Week 4-8 from SoR
measure: Change from SoR to End of Ramadan (EoR) in the 5-Level European Quality of Life 5 Dimensions (EQ-5D-5L)
timeFrame: SoR (Week 0), EoR (Week 4)
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Fahad Armed Forces
state: Al Andalus
city: Alahsa
country: Saudi Arabia
facility: Al Moosa Hospital
state: Al Mubarraz
city: Jeddah
country: Saudi Arabia
facility: Saudi Airlines Medical services
state: AlKhalidiyyah
city: Riyadh
country: Saudi Arabia
facility: Dr Sulaiman Al Habib Medical Group-Olaya
state: Alolaya
city: Riyadh
country: Saudi Arabia
facility: Dr Sulaiman Al Habib Medical Group-Alsuwaidi
state: Alsuwaidi,Riyadh
city: Riyadh
country: Saudi Arabia
facility: Dr Sulaiman Al Habib Medical Group-Arrayan
state: Ar Rayyan
city: Riyadh
country: Saudi Arabia
facility: Dallah Hospitals
state: Nakheel, Riyadh
city: Alahsa
country: Saudi Arabia
facility: King Abdulaziz Medical City-Alahsa
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz Medical City-Jeddah
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Abu Dhabi
country: United Arab Emirates
facility: ICLDC
city: Abu Dhabi
country: United Arab Emirates
facility: NMC Speciality Hospital
city: Ajman
country: United Arab Emirates
facility: Rashid Center for Diabetes&Research
city: Ajman
country: United Arab Emirates
facility: Thumbay University Hospital
city: Dubai
country: United Arab Emirates
facility: Aster Clinics
city: Dubai
country: United Arab Emirates
facility: Dubai Diabetes Center
city: Dubai
country: United Arab Emirates
facility: Dubai Hospital
city: Dubai
country: United Arab Emirates
facility: Medcare Hospital
city: Dubai
country: United Arab Emirates
facility: Mediclinic City Hospital
city: Dubai
country: United Arab Emirates
facility: Rashid Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: