DelfaGLP-1 Atlas

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TIRTLE2

Not yet recruitingPhase 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)

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

44

estimated

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criteria

•BMI ≥27•HbA1c ≤9%

Primary endpoint

•HOMA-IR (insulin sensitivity)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06820281
Org study IDU1111-1316-2752

Timeline

Milestones

Study first posted2025-02-11actual
Last update posted2026-05-19actual
Study start2026-07-01estimated
Primary completion2027-12-31estimated
Study completion2027-12-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•age 18-65 years
•BMI ≥ 27 kg/m2
•HbA1c ≤ 9.0%
•insulin delivery using an automated insulin delivery system
•at least 2 years since diagnosis of type 1 diabetes

Exclusion criteria

•TZP or GLP-1 receptor agonist in last 3 months; metformin or sodium glucose co-transporter 2 (SGLT2) inhibitor in the last 6 weeks; steroids, antipsychotics, immunosuppressants in the last 6 weeks.
•Hypoglycemic unawareness or severe hypoglycemia last 6 months.
•History of seizure disorder.
•History of weight loss surgery.
•eGFR <60 mL/min/1.73 m2.
•Liver disease (known cirrhosis, LFTs > 3x upper limit of normal).
•Active malignancy.
•Pregnant, breastfeeding, planning pregnancy within 6 months, or not using adequate contraception.
•History of cardiovascular disease, or coronary event or stroke in last 3 months
•Hemoglobin level < 13.5 g/dL in men, < 12.0 g/dL in women

Endpoints (44)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
15
Glycemic / diabetes
13
Cardiometabolic biomarkers
7
Weight & body composition
3
Safety / tolerability / PK
2
Other clinical outcomes
2
MASH / liver
1
Patient-reported / QoL
1

Weight & body composition

3 endpoints
Other/protocol endpoint

Body weight

Time frame:6 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

% fat free mass

Time frame:6 weeks

Lean mass

change from baseline, improvement

Other/protocol endpoint

% fat mass

Time frame:6 weeks

Total fat mass

change from baseline, improvement

Glycemic / diabetes

13 endpoints
Primary/protocol endpoint

Whole-body insulin sensitivity

Time frame:6 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Prandial glucagon secretion

Time frame:6 weeks

change from baseline, improvement

Secondary/protocol endpoint

Glucagon response to hypoglycemia

Time frame:6 weeks

change from baseline, improvement

Secondary/protocol endpoint

Total daily insulin dose

Time frame:6 weeks

change from baseline, improvement

Secondary/protocol endpoint

Total daily basal insulin dose

Time frame:6 weeks

change from baseline, improvement

Secondary/protocol endpoint

Total daily bolus insulin dose

Time frame:6 weeks

change from baseline, improvement

Secondary/protocol endpoint

% Time in Range (TIR)

Time frame:6 weeks

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

% Time Below Range (TBR)

Time frame:6 weeks

CGM time-below-range

change from baseline, improvement

Secondary/protocol endpoint

% Time level 1 hyperglycemia

Time frame:6 weeks

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

% Time level 2 hyperglycemia

Time frame:6 weeks

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Glycemic variability

Time frame:6 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Glucose requirement to correct hypoglycemia

Time frame:6 weeks

change from baseline, improvement

Other/protocol endpoint

HbA1c

Time frame:6 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

1 endpoint
Other/protocol endpoint/low confidence

Fasting liver function tests

Time frame:6 weeks

change from baseline, improvement

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Overnight free-fatty acids (FFA) curve

Time frame:6 weeks

Free fatty acids, change

change from baseline, improvement

Other/protocol endpoint

Lipid profile

Time frame:6 weeks

change from baseline, improvement

Other/protocol endpoint

Systolic blood pressure

Time frame:6 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other/protocol endpoint

Diastolic blood pressure

Time frame:6 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Other/protocol endpoint

Arterial stiffness

Time frame:6 weeks

change from baseline, improvement

Other/protocol endpoint

Arterial stiffness

Time frame:6 weeks

change from baseline, improvement

Other/protocol endpoint

Pulse rate

Time frame:6 weeks

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Other/protocol endpoint

Diabetes Treatment Satisfaction

Time frame:6 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

% Time level 2 hypoglycemia

Time frame:6 weeks

CGM time-below-range

change from baseline, event

Secondary/protocol endpoint

% Time level 1 hypoglycemia

Time frame:6 weeks

Documented hypoglycemia

change from baseline, event

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint/low confidence

Gastric emptying

Time frame:6 weeks

change from baseline, descriptive

Other/protocol endpoint

Diet composition

Time frame:6 weeks

change from baseline, descriptive

Other (unclassified)

15 endpoints
Secondary/protocol endpoint/low confidence

Resting energy expenditure (REE)

Time frame:6 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Overnight growth hormone curve

Time frame:6 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Metanephrine response to hypoglycemia

Time frame:6 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Normetanephrine response to hypoglycemia

Time frame:6 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Growth hormone response to hypoglycemia

Time frame:6 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Cortisol response to hypoglycemia

Time frame:6 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Prandial GLP1 secretion

Time frame:6 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Prandial GIP secretion

Time frame:6 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Fasting glucagon

Time frame:6 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Fasting GLP1

Time frame:6 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Fasting GIP

Time frame:6 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Supraclavicular temperature profile

Time frame:6 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Growth differentiation factor 15 (GDF15)

Time frame:6 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

C-terminal telopeptide of type 1 collagen

Time frame:6 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Procollagen type 1 N-terminal propeptide

Time frame:6 weeks

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.