DelfaGLP-1 Atlas

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TZP

RecruitingPhase 2, PHASE3

A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar

Fully Closed-Loop Glucose Control in Adults With Type 1 Diabetes Using Tirzepatide: a Randomized, Multi-center, Open-label, Non-inferiority, Parallel Trial

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

4

Recruiting sites

1

Enrollment

105

estimated

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criteria

•BMI ≥27•HbA1c ≥6.5%

Primary endpoint

•CGM time-in-range

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 IDNCT07284511
Org study ID2026-12143

Timeline

Milestones

Study first posted2025-12-16actual
Study start2026-05-19actual
Last update posted2026-05-27actual
Primary completion2028-01estimated (month precision)
Study completion2029-01estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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.
•HbA1c > 6.5%, and < 12%.
•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)
•Active carbohydrate counting for prandial insulin dosing.
•Individuals of childbearing potential must be using or agree to use an effective birth-control method. Childbearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a medical condition causing sterility (e.g., hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.

Exclusion criteria

•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.
•Breastfeeding.
•Severe hypoglycemia requiring hospitalization in the past 2 months. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.
•Diabetic ketoacidosis within the last 2 months.
•History of acute or chronic pancreatitis.
•Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.
•Severe renal impairment with eGFR <30 mL/min/1.73 m2 (CKD-EPI), measured within the last four months.
•Clinically significant proliferative diabetic retinopathy or gastroparesis, as per the judgment of the investigator.
•Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids.
•History of bariatric surgery within the last 6 months.
•Medical or psychiatric illness likely to interfere with participation (e.g. cirrhosis, active cancer, decompensated schizophrenia), per investigator judgment.
•Inability or unwillingness to comply with safe diabetes management practices, in the view of the investigator.
•Any safety concern that, in the investigator's judgment, precludes participation.

Endpoints (35)

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

Cardiometabolic biomarkers
7
Weight & body composition
6
Glycemic / diabetes
5
Safety / tolerability / PK
5
Other (unclassified)
4
Renal / kidney
3
Patient-reported / QoL
3
Heart failure
1
Other clinical outcomes
1

Weight & body composition

6 endpoints
Secondary/protocol endpoint

Weight

Time frame:At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Height

Time frame:At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study.

change from baseline, descriptive

Secondary/protocol endpoint

Body Mass Index

Time frame:At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Waist-to-Hip Ratio

Time frame:At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study.

ratio, improvement

Secondary/protocol endpoint

DXA Body Composition

Time frame:At enrollment and at Week 32 (site-dependent).

descriptive

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Daytime Time-in-Range

Time frame:During the final 6 weeks of the study

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Insulin-related measures

Time frame:Continuously from randomization through Week 32, with primary analysis focused on Weeks 27-32, At Week 8 and Week 16 post-study.

change from baseline, improvement

Secondary/protocol endpoint

Glucose outcomes

Time frame:Continuously collected from randomization through Week 32, with key comparisons during Weeks 23-26 and Weeks 27-32, At Week 8 and Week 16 post-study.

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Glycated Hemoglobin (HbA1c)

Time frame:At enrollment, mid-study at Week 16, and at the end-of-study visit at Week 32, At Week 8 and Week 16 post-study.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

C-Peptide

Time frame:At enrollment and at Week 32, At Week 8 and Week 16 post-study.

C-peptide AUC

change from baseline, improvement

Heart failure

1 endpoint
Secondary/protocol endpoint

Cardiac Biomarkers (NT-proBNP)

Time frame:At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

NT-proBNP, change

change from baseline, improvement

Renal / kidney

3 endpoints
Secondary/protocol endpoint

Estimated Glomerular Filtration Rate

Time frame:At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Serum Creatinine

Time frame:At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

change from baseline, improvement

Secondary/protocol endpoint

Albumin-to-Creatinine Ratio

Time frame:At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Systolic Blood Pressure

Time frame:At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study.

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic Blood Pressure

Time frame:At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study.

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Resting Heart Rate

Time frame:At enrollment, Week 8, Week 16, Week 24, and Week 32, At Week 8 and Week 16 post-study.

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)

Time frame:At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

change from baseline, improvement

componentsTotal cholesterol, change, LDL-C, change, HDL-C, change, Triglycerides, change

Secondary/protocol endpoint

Inflammatory Biomarkers (hs-CRP)

Time frame:At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Inflammatory Biomarkers (IL-6)

Time frame:At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

concentration, descriptive

Secondary/protocol endpoint

Carotid-Femoral Pulse Wave Velocity and Pulse Wave Analysis

Time frame:At enrollment and at Week 32 (site-dependent).

change from baseline, improvement

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint

Quality-of-Life Measures (Diabetes Distress Scale)

Time frame:At enrollment and at Week 32.

change from baseline, improvement

Secondary/protocol endpoint

Quality-of-Life Measures (Hypoglycemia Fear Survey II)

Time frame:At enrollment and at Week 32.

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Quality-of-Life Measures (Three Factor Eating r18 Questionnaire)

Time frame:At enrollment and at Week 32.

change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Liver Function Markers (Alanine transaminase, Alkaline phosphatase)

Time frame:At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

change from baseline, descriptive

Secondary/protocol endpoint

Liver Function Markers (Bilirubin)

Time frame:At enrollment, Week 16, and Week 32, At Week 8 and Week 16 post-study.

change from baseline, descriptive

Other/protocol endpoint

Severe hypoglycemia

Time frame:From the time the participant signs informed consent until the end of study participation at Week 32, with additional safety follow-up at Week 8 and Week 16 post-study.

Severe hypoglycemia

event count, event

Other/protocol endpoint

Diabetic Ketoacidosis

Time frame:From the time the participant signs informed consent until the end of study participation at Week 32, with additional safety follow-up at Week 8 and Week 16 post-study.

event count, event

Other/protocol endpoint

Gastrointestinal and related side effects

Time frame:From the time the participant signs informed consent until the end of study participation at Week 32, with additional safety follow-up at Week 8 and Week 16 post-study.

descriptive, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

VO₂-max Test

Time frame:At enrollment and at Week 32 (site-dependent).

descriptive

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Echocardiogram (Diastolic Function Parameters)

Time frame:At enrollment and at Week 32 (site-dependent).

descriptive

Secondary/protocol endpoint/low confidence

Gastric Emptying via [13C] Acetate Breath Test

Time frame:At enrollment (or training visit) and at Week 32 (site-dependent).

descriptive

Secondary/protocol endpoint/low confidence

Blood Glucagon Response to Standardized Meal

Time frame:At enrollment and at Week 32 (site-dependent).

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Meal Tracking Using Keenoa or MyFood24

Time frame:Prior to randomization, during Week 16, and during Week 32.

descriptive

Publications (21)

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.