Tirzepatide Use in People With Obesity and Type 1 Diabetes

Sponsor
Dasman Diabetes Institute
Study ID
NCT07096908
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    weekly injections
  • Placebo — DRUG
    weekly injections

Study Details

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.

Key Dates

Start date
Jul 31, 2025
Status verified
Apr 2026
Primary completion
Feb 25, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Tirzepatide subcutaneous injections will be given weekly for 76 weeks. Starting dose will be 2.5mg and dose will be increased gradually, by increments of 2.5mg, every 4 weeks to reach 15 mg at week 24 based on patient's tolerability of side effects (i.e. starting dose 2.5 mg, then dose will be increased to 5 mg, 7.5mg,10 mg, 12.5mg then finally 15 mg).
  • Placebo Comparator: Placebo
    an equivalent volume of normal saline 0.9% will be given to the placebo arm.

Primary Outcome Measure

Bodyweight [ Time Frame: 76 weeks ]

Central Contacts

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