Tirzepatide Use in People With Obesity and Type 1 Diabetes

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Type1diabetes, Obesity

In brief

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 facts

Study ID

NCT07096908

Run by

Dasman Diabetes Institute

People needed

60

Starts

2025-07-31

Expected to finish

2028-08-01

Last updated by the study team

2026-04-20

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• History of at least one self-reported unsuccessful dietary effort to lose body weight.
• Must be using a Continuous Glucose Monitoring (CGM) device for at least 2 months before the screening visit and be willing to wear a CGM device for the duration of the study.

You may not qualify if…

• Diabetes related:
• 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.
• Experienced severe hypoglycemia (Level 3) within 6 months of screening visit.
• Obesity-related:
• A self-reported change in body weight >5 kg (11 lbs) within 90 days before screening irrespective of medical records.
• Treatment with any medication for the indication of obesity within the past 90 days before screening.
• Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening; (2) lap banding, if the band has been removed >1 year before screening; (3) intragastric balloon, if the balloon has been removed >1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed >1 year before screening.
• Uncontrolled thyroid disease, defined as thyroid stimulating hormone >6.0 mIU/L or <0.4 mIU/L as measured by the central laboratory at screening.
• Mental health:
• History of major depressive disorder within 2 years before screening.
• Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder).
• A Patient Health Questionnaire-9 score of ≥15 at screening.
• A lifetime history of a suicidal attempt.
• Suicidal behavior within 30 days before screening.
• Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale within the past 30 days before screening.
• General safety:
• Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening.
• Presence of acute pancreatitis within the past 180 days prior to the day of screening.
• History or presence of chronic pancreatitis.
• Calcitonin ≥100 ng/L as measured by the central laboratory at screening.
• Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
• Renal impairment measured as estimated glomerular filtration rate value of <15 mL/min/1.73m2 as defined by KDIGO 2012 by the central laboratory at screening.

Where it is running

• Dasman Diabetes Institute — Kuwait City, Sharq, Kuwait (enrolling)

Full record on ClinicalTrials.gov

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