A Phase 4 interventional study of Tirzepatide and Placebo in Type1diabetes and Obesity, sponsored by Dasman Diabetes Institute. Recruiting at 1 site in Kuwait. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Dasman Diabetes Institute · Phase 4, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Dasman Diabetes Institute is the lead sponsor of 31 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diabetes related:
Obesity-related:
Mental health:
General safety:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
an equivalent volume of normal saline 0.9% will be given to the placebo arm.
Drug: Placebo
weekly injections
weekly injections
Also known as: Normal Saline 0.9%
Bodyweight
Percent body weight change (%)
Time frame: 76 weeks
HbA1c
Change in HbA1c levels (%)
Time frame: 76 weeks
Time in range
Change in continuous glucose monitoring (CGM) metrics (time in range (3.9-10mmol/L))
Time frame: 76 weeks
Systolic Blood pressure
Change in blood pressure
Time frame: 76 weeks
Diastolic Blood pressure
Change in blood pressure
Time frame: 76 weeks
Time in hypoglycaemia
Change in continuous glucose monitoring (CGM) metrics (time in hypoglycaemia (mild \< 3.9, severe \< 2.5mmol/L))
Time frame: 76 weeks
Total cholesterol
Change in lipid parameters (total cholesterol)
Time frame: 76 weeks
HDL
Change in lipid parameters (HDL)
Time frame: 76 weeks
Triglycerides
Change in lipid parameters (Triglycerides)
Time frame: 76 weeks
LDL
Change in lipid parameters (LDL)
Time frame: 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.
Time frame: 76 weeks
CRP
Inflammatory markers will be assessed through blood tests.
Time frame: 76 week
Diastolic cardiac function on MRI
Diastolic cardiac function on MRI is primarily assessed by analyzing the left ventricular (LV) filling patterns and myocardial mechanics during diastole, the heart's relaxation and filling phase. Left ventricle filling curves will be measured by tracing the endocardial and epicardial borders, Left ventricle volume curves will show the changes in left ventricle volume during diastole.
Time frame: 76 weeks
Liver stiffness
Liver stiffness as caused by liver fat will be assessed using MRI
Time frame: 76 weeks
Kidney Disease: Improving Global Outcomes (KDIGO) score for Diabetic nephropathy
The KDIGO (Kidney Disease: Improving Global Outcomes) score for diabetic nephropathy will be used as it combines eGFR and urine albumin creatinine ratio. The stages of diabetic nepropathy starts from 1 and increases to 5. A higher score indicates worse diabetic nephropathy.
Time frame: 76 weeks
Diabetic Retinopathy Severity Scale (DRSS)
The Diabetic Retinopathy Severity Scale (DRSS) is the primary score used to assess the severity of diabetic retinopathy, according to Retina Today. It ranges from level 10 (normal) to level 85 (advanced proliferative diabetic retinopathy).
Time frame: 76 weeks
Fat mass: fat free mass ratio
Body composition will be assessed using dual-energy X-ray absorptiometry (DXA).
Time frame: 76 weeks
Incidence of treatment emergent events
Side effects of medications
Time frame: 76 weeks
Functional improvements in quality of life
Quality of life will be assessed using SF-36 questionnaires. Scores for the functional domain range from 0 to 100, with a higher score defining a more favorable health state.
Time frame: 76 weeks
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tirzepatide
Dasman Diabetes Institute