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A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar
Plain-language guide to NCT07284511: phase 2, phase 3 randomized trial of Tirzepatide, 105 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07284511
- Phase
- phase 2, phase 3
- Status
- recruiting participants
- Start
- 2026-05-19
- Completion (planned or actual)
- 2028-01
- Participants
- 105 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 1 Diabetes; Type 1 Diabetes Mellitus; T1D; T1DM; T1DM - Type 1 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2, phase 3 trial tested Tirzepatide.
People with type 1 diabetes must take insulin for life, and even with advanced insulin pumps and continuous glucose monitors, many still struggle to keep blood sugar within the target range.
It had two arms (groups): Tirzepatide group (experimental) and Control group (active comparator).
The registry classes the interventions as behavioral, device and drug.
More on the Plan
In this 32-week trial, 105 adults will be randomly assigned to receive tirzepatide or no tirzepatide while all participants use the Control-IQ system.
Across the study, participants will attend scheduled clinic visits, complete remote follow-ups, undergo laboratory tests, and, depending on the site, may complete heart function tests, body-composition scans, fitness testing, or gastric emptying assessments.
Who Took Part
The registry lists 105 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age ≥ 18 years. Clinical diagnosis of type 1 diabetes for ≥ 1 year, per investigator judgment (confirmatory C-peptide and autoantibodies not required). A BMI ≥ 27 kg/m2. Current therapy: multiple daily injections or insulin pump. Willingness to use Tandem Control IQ insulin pump system with the use of rapid or ultra rapid-acting insulins compatible with Tandem Control-IQ pump (e.g. Fiasp is not compatible).
The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: use of glp1-ras within the last four weeks; use of antihyperglycemic agents other than insulin or metformin within the last 2 weeks; planned or ongoing pregnancy.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2026-05-19 with completion listed for 2028-01.
It ran at 4 sites in Canada (3) and Switzerland (1).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Daytime Time-in-Range (time frame: During the final 6 weeks of the study).
It also tracked 31 secondary outcomes, for example Weight, Height, Body Mass Index, Waist circumference, Waist-to-Hip Ratio and Systolic Blood Pressure.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, randomized trial of Tirzepatide in 105 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tirzepatide compound page, all human trials.
Our Notes on the Compound
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.