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Could a weekly shot help tame type 1 diabetes?

NCT ID NCT06630585

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding a weekly medicine called tirzepatide to usual insulin therapy helps adults with type 1 diabetes control their blood sugar better. About 42 people aged 18-65 who already use an automated insulin pump will take part. The goal is to see if the combination leads to more time with blood sugar in a healthy range.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants with diagnosed T1D for at least 12 months. 2. Aged between 18 to 65 years old (inclusive). 3. Currently on AID therapy for at least three months. 4. HbA1C higher or equal to 6.5% and less or equal to 10%. 5. BMI ≥23 kg/m2. 6. Willing to use once-weekly tirzepatide for at least 16 weeks (including four weeks of up-titration and 12 weeks of treatment) 7. Willing to wear a Dexcom G7 Sensor and share devices (AID) data uploads. 8. Willingness not to start any new non-insulin glucose-lowering agent during the trial (including metformin/biguanides, pramlintide, DPP-4 inhibitors, sodium-glucose cotransporter 2 inhibitors \[SGLT2 inhibitors\], and nutraceuticals). 9. A stable weight (± 5%) in the last 90 days or more before the screening and agree to not initiate a diet and/or exercise program during the study to reduce body weight other than the lifestyle and dietary measures for diabetes treatment. 10. Females with childbearing potential and males (if apply) must be willing to use reliable contraceptive methods (for the contraceptives study guidelines. See Annex 7 of the protocol) 11. An understanding and willingness to follow the protocol and signed informed consent. Exclusion Criteria: 1. History of diabetic ketoacidosis requiring hospitalization in the past six months. 2. History of severe hypoglycemic event (Level 3, defined as seizure or loss of consciousness) in the past six months. 3. Uncontrolled Diabetic retinopathy or maculopathy 4. Severe gastroparesis. 5. Less than 12 months of insulin treatment. 6. Estimated glomerular filtration rate (eGFR) lab value below 30 mL/min/1.73 m2 by the CKD-EPI formula(99). 7. Pregnancy or intention to become pregnant during the trial (See annex 7). 8. Currently breastfeeding or planning to breastfeed. 9. Currently uncontrolled seizure disorder. 10. History of allergy to GIP/GLP-1RAs or its excipients. 11. Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or medullary thyroid carcinoma. 12. Screening calcitonin above or equal to 35 ng/L. 13. Planned any surgery during the study duration. 14. Have uncontrolled hypertension (systolic BP above or equal to 160 mmHg and/or diastolic BP above or equal to 100 mmHg). If a participant is on anti-hypertensive therapies, doses must be stable for 30 days before screening. For participants with uncontrolled hypertension at the screening visit, antihypertensive medication may be started or adjusted. 15. Personal history of one of the following cardiovascular conditions (within two months before the screening): acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF). 16. Conditions that may increase the risk of induced hypoglycemia, such as CHF with NYHA Functional Classification III or IV or adrenal insufficiency. 17. Have a history of documented human immunodeficiency virus (HIV) infection. 18. Have an uncontrolled cardiac arrhythmia based on an electrocardiogram (ECG) at the screening time and the investigator's discretion. 19. Cystic fibrosis. 20. Patient with a history of gastric bypass (bariatric) surgery, sleeve gastrectomy, or restrictive bariatric surgery, such as Lap-Band® or gastric banding. 21. Uncontrolled thyroid disease as judged by the investigator 22. Serum triglycerides higher than 5.7 mmol/L (500 mg/dL) at the screening. If a participant is on lipid-lowering therapies, doses must be stable for 30 days before screening. 23. Personal history of acute or chronic pancreatitis. A participant with a history of acute pancreatitis caused by gallstones may be included in the study if the participant has had a cholecystectomy to resolve the problem. 24. Acute or chronic hepatitis other than MASLD. 25. Have a history of symptomatic gallbladder disease within the past two years (unless the participant has had a cholecystectomy to resolve the problem). 26. History of malignancy requiring chemotherapy, surgery, or radiation (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) in the previous five years. 27. Active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (such as known drug or alcohol abuse, diagnosed eating disorder, or any other uncontrolled psychiatric disorder) that, in the investigator's opinion, may preclude the participant from following and completing the protocol. 28. Treatment with non-insulin glucose-lowering agents other than metformin (on a stable dose 30 days before the study) 29. Weight loss medications in the past three months. 30. Participants who are anticipated to receive, are receiving, or have received within three months before the screening (more than two weeks and more or equal to 10mg prednisolone-equivalent) chronic systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, single intraarticular injection, or inhaled preparations). 31. Have current treatment with (or history of, within three months before screening) medications that may significantly affect glucose metabolism. 32. Use of investigational drugs within five half-lives before screening. 33. Participation in another study with an investigational drug within the 30 days preceding and during the present study. 34. Current enrollment in another clinical trial unless approved by the investigator of both studies and if the clinical trial is a non-interventional registry trial. 35. Have evidence of a significant active, uncontrolled medical condition or a history of any medical problem capable of constituting a risk when using the study devices or interfering with following study procedures or the interpretation of data, as judged by the study physician at screening. 36. The enrolment of the investigator, his/her family members, employees, and other dependent persons.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • DiaCenTRE - Hirslanden Clinique des Grangettes

    RECRUITING

    Chêne-Bougeries, Canton of Geneva, 1224, Switzerland

  • Kantonsspital Olten

    RECRUITING

    Olten, Canton of Solothurn, 4600, Switzerland

  • Luzerner Kantonspital

    RECRUITING

    Lucerne, 6000, Switzerland

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Other studies related to the condition(s) this trial covers.