NCT06820281RecruitingPhase 2
Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes
Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes: a Phase 2 Double Blinded Placebo Controlled Clinical Trial (TIRTLE2)
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
This study will examine the effects of Tirzepatide (TZP), a glucagon-like peptide 1 (GLP1) - gastric inhibitory peptide (GIP) co-agonist, on metabolism in type 1 diabetes (T1D). Research participants with T1D will undergo measures of insulin sensitivity, and hormone levels post-meal, post-hypoglycemia and during the overnight period. These measures will be performed prior to, and after 6 weeks of treatment with TZP or placebo.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 6 Feb 2025
- Start date
- 7 Jul 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Victor Chang Cardiac Research Institute
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06820281
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 44
- From 7 Jul 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of seizure disorder.
- History of weight loss surgery.
- Liver disease (known cirrhosis, LFTs \> 3x upper limit of normal).
- Active malignancy.
- Coronary event or stroke in last 6 months
Lab values
- TZP or GLP-1 receptor agonist in last 3 months; metformin or sodium glucose co-transporter 2 (SGLT2) inhibitor in the last 6 weeks; systemic steroids, antipsychotics, in the last 6 weeks.
- eGFR \<60 mL/min/1.73 m2.
- Hemoglobin level \< 13.5 g/dL in men, \< 12.0 g/dL in women
Other
- Hypoglycemic unawareness or severe hypoglycemia last 6 months.
- Pregnant, breastfeeding, planning pregnancy within 6 months, or not using adequate contraception.
- Active or untreated proliferative diabetic retinopathy
Who the study is looking for
- age 18-70 years
- BMI ≥ 25 kg/m2
- HbA1c ≤ 9.0%
- insulin delivery using an automated insulin delivery system
- at least 2 years since diagnosis of type 1 diabetes
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Victor Chang Cardiac Research Institute Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.