Tirzepatide for obesity in people with type 1 diabetes

Treatment With Tirzepatide of the Disease of Obesity in People With Type 1 Diabetes

This trial will test whether tirzepatide helps adults with type 1 diabetes and obesity lose weight and is safe for them.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Dasman Diabetes Institute (other)
• Locations: 1 site (Kuwait City, Sharq)
• Trial ID: NCT07096908 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 4 trial compares usual care plus the maximum tolerable dose of tirzepatide versus placebo in adults with established type 1 diabetes and obesity. Eligible participants must have had type 1 diabetes for at least one year with very low C-peptide, a BMI ≥27 kg/m2, and be using a continuous glucose monitor, while meeting glycemic and retinal safety criteria. The study will track weight loss and safety outcomes—particularly hypoglycemia, diabetic ketoacidosis, and retinopathy—while participants use CGM throughout the trial. The trial is conducted at the Dasman Diabetes Institute in Kuwait with randomized assignment and blinding to minimize bias.

Who should consider this trial

Good fit: Adults with type 1 diabetes for at least one year, very low C-peptide levels, a BMI of 27 kg/m2 or higher, current CGM use, and acceptable HbA1c and retinal status are the intended participants.

Not a fit: People with very high HbA1c (≥10%), recent diabetic ketoacidosis, recent severe hypoglycemia, proliferative retinopathy, recent GLP-1 receptor agonist use, children, or pregnant people are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, tirzepatide could produce substantial weight loss and provide safety data to guide treatment of obesity in people with type 1 diabetes.

How similar studies have performed: Tirzepatide has produced up to ~22% weight loss in obesity trials and about 15% in type 2 diabetes, but its effects and safety profile in people with type 1 diabetes are largely untested.

Eligibility criteria

Inclusion Criteria:

1. Informed consent obtained before any trial-related activities.
2. Male or female, adults.
3. 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.
4. Body mass index (BMI) ≥ 27.0 kg/m2
5. History of at least one self-reported unsuccessful dietary effort to lose body weight.
6. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.
4. 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.
   * History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
   * Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening.
   * Subject presently classified as being in New York Heart Association Class IV.
   * Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.
   * Known or suspected abuse of alcohol or recreational drugs.
   * Known or suspected hypersensitivity to trial product(s) or related products.
   * Previous participation in this trial. Participation is defined as signed informed consent.
   * Participation in another clinical trial within 90 days before screening.
   * Other subject(s) from the same household participating in any semaglutide trial.
   * Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
   * Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.

Where this trial is running

Kuwait City, Sharq

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

Study contacts

• Principal investigator: Ebaa Al Ozairi, MD — Dasman Diabetes Institute
• Study coordinator: Shaikhah M Alghanim, MSC

Conditions: Type1diabetes, Obesity, T1D, tirzepatide, weight loss, obesity