Tirzepatide Use in People With Obesity and Type 1 Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorDasman Diabetes Institute
About this trial
Tirzepatide, a gut hormone-based medication, has shown promising results in treating obesity, with \~22% weight loss and mild side effects. However, patients with type 2 diabetes typically experience only about 15% weight loss with tirzepatide, despite tolerating the medication well. Its effects in people with both obesity and type 1 diabetes remain largely unknown.
Although tirzepatide is not approved for glycemic control in type 1 diabetes, it is licensed for obesity treatment in Gulf and Europe. In Kuwait, more than a quarter of people with type 1 diabetes also have obesity, presenting a unique opportunity to study tirzepatide's impact.
This randomized, double-blind controlled trial will evaluate the safety and efficacy of tirzepatide in patients with type 1 diabetes and obesity, comparing usual care with the maximum tolerable dose of tirzepatide to assess its impact on weight loss. The findings may help address important safety concerns and have the potential to inform and influence future clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent obtained before any trial-related activities.
Male or female, adults.
Documented diagnosis of T1DM (per ADA 2024definition/criteria) for at least 1 year before screening visit with C-peptide level of less than 0.01nm/L.
Body mass index (BMI) ≥ 27.0 kg/m2
Disqualifiers
Glycated hemoglobin (HbA1c) ≥86 mmol/mol (10%) as measured by the central laboratory at screening.
Treatment with a glucagon-like peptide-1 receptor agonist within 180 days before screening.
Preproliferative or proliferative retinopathy
Experienced diabetic ketoacidosis within 6 months of screening visit.
Trial design
Design model
Parallel
Treatments tested in this trial
Tirzepatide
Drugweekly injections
Placebo
Drugweekly injections
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: TirzepatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bodyweight
Percent body weight change (%)
Time frame
76 weeksSecondary outcomes
1
HbA1c
Change in HbA1c levels (%)
Time frame
76 weeks2
Time in range
Change in continuous glucose monitoring (CGM) metrics (time in range (3.9-10mmol/L))
Time frame
76 weeks3
Systolic Blood pressure
Change in blood pressure
Time frame
76 weeks4
Diastolic Blood pressure
Change in blood pressure
Time frame
76 weeksOther outcomes
1
Diastolic cardiac function on MRI
Diastolic cardiac function on MRI is primarily assessed by analyzing the left ventricular (LV) filling patterns and myocardial mechanics during diastole, the heart's relaxation and filling phase. Left ventricle filling curves will be measured by tracing the endocardial and epicardial borders, Left ventricle volume curves will show the changes in left ventricle volume during diastole.
Time frame
76 weeks2
Liver stiffness
Liver stiffness as caused by liver fat will be assessed using MRI
Time frame
76 weeks3
Kidney Disease: Improving Global Outcomes (KDIGO) score for Diabetic nephropathy
The KDIGO (Kidney Disease: Improving Global Outcomes) score for diabetic nephropathy will be used as it combines eGFR and urine albumin creatinine ratio. The stages of diabetic nepropathy starts from 1 and increases to 5. A higher score indicates worse diabetic nephropathy.
Time frame
76 weeks4
Diabetic Retinopathy Severity Scale (DRSS)
The Diabetic Retinopathy Severity Scale (DRSS) is the primary score used to assess the severity of diabetic retinopathy, according to Retina Today. It ranges from level 10 (normal) to level 85 (advanced proliferative diabetic retinopathy).
Time frame
76 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dasman Diabetes Institute
Lead sponsor
University of Ulster
Collaborator
Source ClinicalTrials.gov