Type1diabetesPhase 4NCT07096908
Tirzepatide Use in People With Obesity and Type 1 Diabetes
A Phase 4 study testing Tirzepatide in people with Type1diabetes and Obesity, run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type1diabetes, Obesity
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteKuwait
- Study dates
- 31 Jul 2025to 1 Aug 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kuwait1 site, 1 recruiting
- Recruiting
Dasman Diabetes Institute
Kuwait City, Sharq, 15462
Shaikhah M Alghanim, Masters, 1877877 ext. 1921, shaikhah.alghanim@dasmaninstitute.org
Ebaa Al Ozairi, MD
About this study
Official title: Treatment With Tirzepatide of the Disease of Obesity in People With Type 1 Diabetes
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
- Being tested
- Tirzepatide, Placebo
- Keywords
- T1D, tirzepatide, weight loss, obesity
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
weekly injections
PlaceboDrug
Also called Normal Saline 0.9%
weekly injections
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | an equivalent volume of normal saline 0.9% will be given to the placebo arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bodyweight
Percent body weight change (%)
Measured: 76 weeks
Secondary outcomes (11)
HbA1c
Change in HbA1c levels (%)
Measured: 76 weeks
Time in range
Change in continuous glucose monitoring (CGM) metrics (time in range (3.9-10mmol/L))
Measured: 76 weeks
Systolic Blood pressure
Change in blood pressure
Measured: 76 weeks
Diastolic Blood pressure
Change in blood pressure
Measured: 76 weeks
Time in hypoglycaemia
Change in continuous glucose monitoring (CGM) metrics (time in hypoglycaemia (mild < 3.9, severe < 2.5mmol/L))
Measured: 76 weeks
Total cholesterol
Change in lipid parameters (total cholesterol)
Measured: 76 weeks
HDL
Change in lipid parameters (HDL)
Measured: 76 weeks
Triglycerides
Change in lipid parameters (Triglycerides)
Measured: 76 weeks
LDL
Change in lipid parameters (LDL)
Measured: 76 weeks
SF-36 (36-Item Short Form Survey) for Quality of life
Quality of life will be assessed using SF-36 questionnaires. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: 76 weeks
CRP
Inflammatory markers will be assessed through blood tests.
Measured: 76 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start31 Jul 2025
- Primary completion25 Feb 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster
- Responsible party
- Principal investigator, Dr. Ebaa Al Ozairi, Dasman Diabetes Institute
- Investigators
- Ebaa Al Ozairi, MD, Principal investigator, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096908
- Sponsor's protocol ID
- RA HM-2025-03
- Status last verified
- Apr 2026
- First submitted
- 25 Jun 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al Ozairi E, Al Awadhi A, Taghadom E, Al Kandari J, Alsaeed D, Alghanim S, Mashankar A, Le Roux C. Treatment of the disease of obesity in patients with type 1 diabetes with tirzepatide: a protocol for a randomised controlled trial in a single-centre setting. BMJ Open. 2026 May 7;16(5):e117431. doi: 10.1136/bmjopen-2026-117431.
PubMed 42097660