Tirzepatide Use in People With Obesity and Type 1 Diabetes

NCT07096908 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: RA HM-2025-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Type1diabetes; Obesity

Keywords

T1D; tirzepatide; weight loss; obesity

Outcome Measures

Primary Outcomes (1)

• Bodyweight

  Percent body weight change (%)

  76 weeks

Secondary Outcomes (11)

• HbA1c

  76 weeks

• Time in range

  76 weeks

• Systolic Blood pressure

  76 weeks

• Diastolic Blood pressure

  76 weeks

• Time in hypoglycaemia

  76 weeks

Other Outcomes (7)

• Diastolic cardiac function on MRI

  76 weeks

• Liver stiffness

  76 weeks

• Kidney Disease: Improving Global Outcomes (KDIGO) score for Diabetic nephropathy

  76 weeks

Study Arms (2)

Tirzepatide

EXPERIMENTAL

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).

Drug: Tirzepatide

Placebo

PLACEBO COMPARATOR

an equivalent volume of normal saline 0.9% will be given to the placebo arm.

Drug: Placebo

Interventions

Tirzepatide DRUG

weekly injections

Tirzepatide

Placebo DRUG

weekly injections

Also known as: Normal Saline 0.9%

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Dasman Diabetes Institute: lead
• University of Ulster: collaborator

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, Sharq, 15462, Kuwait

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Tirzepatide; Saline Solution

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ebaa Al Ozairi, MD

  Dasman Diabetes Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaikhah M Alghanim, MSC

CONTACT

965 65533776; shaikhah.alghanim@dasmaninstitute.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical Sector (CMO)

Model Details: The trial is a 76-week, randomized, double-blind, parallel-group, 2- arm, trial comparing maximal tolerable dose of tirzepatide up to 15mg once weekly with placebo once weekly in participants with a BMI ≥27 kg/m2 and T1DM.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 31, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): February 25, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

KU (1)