DelfaGLP-1 Atlas

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TZP-T1D

Not yet recruitingPhase 2

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

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

0

Recruiting sites

—

Enrollment

40

estimated

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criteria

•BMI ≥27•HbA1c ≤10%

Primary endpoint

•Body weight, % change

Identifiers

Registered as

NCT IDNCT06180616
Org study IDTZP-T1D

Timeline

Milestones

Study first posted2023-12-22actual
Last update posted2025-07-29actual
Study start2026-12estimated (month precision)
Primary completion2028-12estimated (month precision)
Study completion2028-12estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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
•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

Exclusion criteria

•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
•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

Endpoints (27)

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

Glycemic / diabetes
12
Cardiometabolic biomarkers
7
Weight & body composition
2
MASH / liver
2
Renal / kidney
2
Other (unclassified)
2

Weight & body composition

2 endpoints
Primary/protocol endpoint

Body weight

Time frame:32 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Waist and neck circumference

Time frame:32 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

12 endpoints
Secondary/protocol endpoint

hbA1c

Time frame:32 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time in range

Time frame:32 weeks

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Total daily insulin dose

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Insulin carbohydrate ratio

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Mean glucose

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Time in hypoglycaemia

Time frame:32 weeks

CGM time-below-range

change from baseline, improvement

Secondary/protocol endpoint

Time in hyperglycaemia

Time frame:32 weeks

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Continuous glucose monitoring

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Continuous glucose monitoring

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Continuous glucose monitoring

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Continuous glucose monitoring

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Continuous glucose monitoring

Time frame:32 weeks

change from baseline, improvement

MASH / liver

2 endpoints
Secondary/protocol endpoint

HSI

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

FIB-4

Time frame:32 weeks

change from baseline, improvement

Renal / kidney

2 endpoints
Secondary/protocol endpoint

ACR

Time frame:32 weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

eGFR

Time frame:32 weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Blood pressure

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Total cholesterol

Time frame:32 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Triglyceride

Time frame:32 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

LDL-C

Time frame:32 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

HDL-C

Time frame:32 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Arterial Stiffness using a Pulse Wave Tonometer

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint

Aortic Stiffness using a Pulse Wave Tonometer

Time frame:32 weeks

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Brachial-Ankle Pulse Wave Velocity using Ankle Brachial Index Machine

Time frame:32 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Left Ventricular Strain using Electrocardiogram

Time frame:32 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.