AzTrials
AzTrials

Type 1 Diabetes MellitusPhase 2TZP-T1DNCT06180616

Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity

A Phase 2 study testing Tirzepatide in people with Type 1 Diabetes Mellitus and Overweight and Obesity, run by Royal North Shore Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial summary

This study is a 2-arm, double blinded, randomised clinical trial where 40 participants will be assigned 1:1 to insulin treatment alone (control) or insulin treatment and tirzepatide treatment for 32 weeks. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Dec 2026to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years at screening
  • A clinical diagnosis of T1D for at least 12 months at time of screening
  • Body mass index ≥ 27kg/m2
  • HbA1c ≤ 10%
  • Capable and willing to self-inject tirzepatide once per week
  • In women of childbearing potential, a negative pregnancy test and willing to use effective contraception consistently for the duration of the study
Show all 12Show fewer
  • Able and willing to provide written informed consent for study participation
  • Able and willing to use Easy Diet Diary
  • Able and willing to keep an exercise log
  • Willing to share devices data uploads
  • Has current glucagon product to treat severe hypoglycaemia
  • Has current ketone meters to check ketones

Who cannot join

  • Age <18 years and >70 years
  • A clinical diagnosis of diabetes type other than T1D
  • HbA1c > 10%
  • Use of GLP-1 receptor agonist within 1 month of study screening
  • Use of any glucose lowering medications aside from insulin within 1 month of study screening
  • History of hypersensitivity to investigational medicinal product or related product
Show all 32Show fewer
  • Obesity that is induced by other endocrine disorders
  • Pregnancy or positive pregnancy test at time of screening, or unwilling to use effective contraception consistently for the duration of the study which is defined in Appendix 1
  • Active proliferative diabetic retinopathy, maculopathy, or severe no proliferative diabetic retinopathy requiring acute treatment
  • Known gastric emptying abnormality
  • History of chronic or acute pancreatitis, uncontrolled hypertension, acute cardiovascular condition within 3 months
  • No longer than 12 months of insulin treatment
  • Not willing to use a NovoPen 6 to record insulin dosing if currently using multiple daily injections
  • Insulin pump, CGM or smart phone devices are not compatible for data transfer
  • Not willing to share device data
  • Current use of any steroidal medication, or planned long-term steroidal treatment (>4 weeks) during the study period
  • Serum triglycerides >500 mg/dL
  • History of or plans for bariatric surgery during the study period
  • eGFR <45 ml/min/1.73 m2
  • History of severe hypoglycaemia (within 3 months of trial period)
  • History of diabetic ketoacidosis (within 3 months of trial period)
  • History of stroke (within 3 months of trial period)
  • History of heart failure
  • Planned coronary, carotid, or peripheral artery revascularisation
  • History of acute or chronic liver disease
  • History of allergy to any form of insulin, GLP-1RA or its excipients
  • History of malignancy requiring chemotherapy, surgery, or radiation (within 5 years of trial period)
  • History of multiple endocrine neoplasia type 2, familial thyroid cancer, or non-familial medullary thyroid cancer
  • Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia) within 5 years before screening
  • Have a pacemaker, or metal implants
  • Participation in other intervention trials during the study period
  • Existence of any additional health conditions or medical issues, including significant psychiatric disorders, that render a person unfit for the study at the discretion of the investigators

About this study

Official title: Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity: A Placebo-Matched Randomised Controlled Trial

This study is a 2-arm, double blinded, randomised clinical trial where 40 participants will be assigned 1:1 to insulin treatment alone (control) or insulin treatment and tirzepatide treatment for 32 weeks. The primary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks adjunctive to insulin treatment can reduce body weight in patients with T1D and overweight or obesity when compared to insulin treatment alone. The secondary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks can improve glycaemic control (measured by hbA1c), improve time in range, reduce insulin requirements, and reduce the severity of comorbidities in people with obesity and T1D. This trial includes a 6 month follow-up period.

Being tested
Tirzepatide
Keywords
Tirzepatide, GLP-1/GIP Agonist
Medical subject headings
Diabetes Mellitus, Type 1, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Tirzepatide will be self-administered subcutaneously by study participants via an injection. The drug will be taken weekly following the schedule: 4 weeks at 2.5 mg QW, 4 weeks at 5.0 mg QW, 4 weeks at 7.5 mg QW, 4 weeks at 10.0 mg QW, 4 weeks at 12.5 mg QW, 12 weeks at 15 mg QW.

    Modification of study drug will be performed if the participant is experiencing significant side effects and cannot tolerate the higher dosage of the study drug. In this instance, the study drug dosage will be reduced to the previously tolerated dosage and held at this dose for a further 4 weeks. One further attempt at dose escalation will be undertaken after 4 weeks, at the discretion of the participant and the study investigator. If recurrent side effects are experienced by the participant, the study drug will be returned to the previously tolerated dosage, and the prescription continued at this dosage for the remainder of the study.

Study groups in NCT06180616
Study groupRoleWhat they receive
Insulin TreatmentNo interventionParticipants will remain on their typical insulin therapy regime for 32 weeks
Tirzepatide TreatmentExperimentalParticipants will remain on their typical insulin therapy regime and will also receive tirzepatide (dose incremented to 15mg QW) for 32 weeks.
Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight

    Percent body weight change (%)

    Measured: 32 weeks

Secondary outcomes (26)

  1. hbA1c

    Change in hbA1c levels (%)

    Measured: 32 weeks

  2. Time in range

    Change in continuous glucose monitoring (CGM) metrics (time in range (3.9-10mmol/L))

    Measured: 32 weeks

  3. Total daily insulin dose

    Change in insulin dose (total daily dose, units/kg of body weight)

    Measured: 32 weeks

  4. Insulin carbohydrate ratio

    Change in insulin dose (insulin carbohydrate ratio (units per g))

    Measured: 32 weeks

  5. Waist and neck circumference

    Change in waist and neck circumference

    Measured: 32 weeks

  6. Blood pressure

    Change in blood pressure

    Measured: 32 weeks

  7. Mean glucose

    Change in continuous glucose monitoring (CGM) metrics (mean glucose)

    Measured: 32 weeks

  8. Time in hypoglycaemia

    Change in continuous glucose monitoring (CGM) metrics (time in hypoglycaemia (mild < 3.9, severe < 2.5mmol/L))

    Measured: 32 weeks

  9. Time in hyperglycaemia

    Change in continuous glucose monitoring (CGM) metrics (time in hyperglycaemia (mild >10, severe 13.9mmol/L))

    Measured: 32 weeks

  10. Continuous glucose monitoring

    Change in continuous glucose monitoring (CGM) metrics (SD)

    Measured: 32 weeks

  11. Continuous glucose monitoring

    Change in continuous glucose monitoring (CGM) metrics (CV)

    Measured: 32 weeks

  12. Continuous glucose monitoring

    Change in continuous glucose monitoring (CGM) metrics (CONGA)

    Measured: 32 weeks

  13. Continuous glucose monitoring

    Change in continuous glucose monitoring (CGM) metrics (J-index)

    Measured: 32 weeks

  14. Continuous glucose monitoring

    Change in continuous glucose monitoring (CGM) metrics (MAGE)

    Measured: 32 weeks

  15. Total cholesterol

    Change in lipid parameters (total cholesterol)

    Measured: 32 weeks

  16. Triglyceride

    Change in lipid parameters (triglyceride)

    Measured: 32 weeks

  17. LDL-C

    Change in lipid parameters (LDL-C)

    Measured: 32 weeks

  18. HDL-C

    Change in lipid parameters (HDL-C)

    Measured: 32 weeks

  19. ACR

    Change in albumin to creatinine ratio (ACR)

    Measured: 32 weeks

  20. eGFR

    Change in renal function (eGFR)

    Measured: 32 weeks

  21. HSI

    Change in NAFLD biomarker HSI. Hepatic steatosis defined as HSI > 36

    Measured: 32 weeks

  22. FIB-4

    Change in NAFLD biomarker FIB-4. Hepatic steatosis defined as FIB-4 index ≥ 1.3 or < 1.3

    Measured: 32 weeks

  23. Brachial-Ankle Pulse Wave Velocity using Ankle Brachial Index Machine

    Change in Brachial-Ankle Pulse Wave Velocity (baPWV)

    Measured: 32 weeks

  24. Arterial Stiffness using a Pulse Wave Tonometer

    Change in arterial stiffness

    Measured: 32 weeks

  25. Aortic Stiffness using a Pulse Wave Tonometer

    Change in aortic stiffness

    Measured: 32 weeks

  26. Left Ventricular Strain using Electrocardiogram

    Change in left ventricular strain

    Measured: 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2023
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06180616
Sponsor's protocol ID
TZP-T1D
Acronym
TZP-T1D
Status last verified
Jul 2025
First submitted
21 Nov 2023
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data related to the primary and secondary outcomes may be shared upon reasonable request following publication. Data sharing will be considered for ethically approved research purposes and subject to data use agreements. IPD will not be shared if legal, ethical, or institutional constraints prevent it.

Publications

  • Purcell AR, Rodrigo N, Longfield MSG, Glastras SJ. Tirzepatide for the treatment of adults living with concurrent type 1 diabetes and overweight or obesity (TZP-T1D): a double-blind, placebo-matched randomised controlled trial protocol. BMJ Open. 2025 Sep 16;15(9):e093775. doi: 10.1136/bmjopen-2024-093775.

    PubMed 40962353

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirzepatide in people with Type 1 Diabetes Mellitus and Overweight and Obesity, run by Royal North Shore Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight (time frame: 32 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06180616, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in