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Tirzepatide Use in People With Obesity and Type 1 Diabetes

NCT07096908 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Tirzepatide

weekly injections

DRUG

Placebo

weekly injections

Sponsors & Collaborators

  • University of Ulster

    collaborator OTHER

  • Dasman Diabetes Institute

    lead OTHER

Principal Investigators

  • Ebaa Al Ozairi, MD · Dasman Diabetes Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2028-02-25
Completion
2028-08-01
FDA Drug
Yes

Countries

  • Kuwait

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07096908 on ClinicalTrials.gov