DelfaGLP-1 Atlas

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RecruitingPhase 4

Tirzepatide Use in People With Obesity and Type 1 Diabetes

Treatment With Tirzepatide of the Disease of Obesity in People With Type 1 Diabetes

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criterion

•BMI ≥27

Primary endpoint

•Body weight, % change

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 IDNCT07096908
Org study IDRA HM-2025-03

Timeline

Milestones

Study first posted2025-07-31actual
Study start2025-07-31actual
Last update posted2026-04-20actual
Primary completion2028-02-25estimated
Study completion2028-08-01estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age21 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Informed consent obtained before any trial-related activities.

2. Male or female, adults.

3. Documented diagnosis of T1DM (per ADA 2024definition/criteria) for at least 1 year before screening visit with C-peptide level of less than 0.01nm/L.

4. Body mass index (BMI) ≥ 27.0 kg/m2

5. History of at least one self-reported unsuccessful dietary effort to lose body weight.

6. Must be using a Continuous Glucose Monitoring (CGM) device for at least 2 months before the screening visit and be willing to wear a CGM device for the duration of the study.

Exclusion criteria

1. Diabetes related:

–Glycated hemoglobin (HbA1c) ≥86 mmol/mol (10%) as measured by the central laboratory at screening.
–Treatment with a glucagon-like peptide-1 receptor agonist within 180 days before screening.
–Preproliferative or proliferative retinopathy
–Experienced diabetic ketoacidosis within 6 months of screening visit.
–Experienced severe hypoglycemia (Level 3) within 6 months of screening visit.

2. Obesity-related:

–A self-reported change in body weight >5 kg (11 lbs) within 90 days before screening irrespective of medical records.
–Treatment with any medication for the indication of obesity within the past 90 days before screening.
–Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening; (2) lap banding, if the band has been removed >1 year before screening; (3) intragastric balloon, if the balloon has been removed >1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed >1 year before screening.
–Uncontrolled thyroid disease, defined as thyroid stimulating hormone >6.0 mIU/L or <0.4 mIU/L as measured by the central laboratory at screening.

3. Mental health:

–History of major depressive disorder within 2 years before screening.
–Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder).
–A Patient Health Questionnaire-9 score of ≥15 at screening.
–A lifetime history of a suicidal attempt.
–Suicidal behavior within 30 days before screening.
–Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale within the past 30 days before screening.

4. General safety:

–Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening.
–Presence of acute pancreatitis within the past 180 days prior to the day of screening.
–History or presence of chronic pancreatitis.
–Calcitonin ≥100 ng/L as measured by the central laboratory at screening.
–Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
–Renal impairment measured as estimated glomerular filtration rate value of <15 mL/min/1.73m2 as defined by KDIGO 2012 by the central laboratory at screening.
–History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
–Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening.
–Subject presently classified as being in New York Heart Association Class IV.
–Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.
–Known or suspected abuse of alcohol or recreational drugs.
–Known or suspected hypersensitivity to trial product(s) or related products.
–Previous participation in this trial. Participation is defined as signed informed consent.
–Participation in another clinical trial within 90 days before screening.
–Other subject(s) from the same household participating in any semaglutide trial.
–Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
–Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.

Endpoints (19)

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
2
Glycemic / diabetes
2
Patient-reported / QoL
2
Safety / tolerability / PK
2
MASH / liver
1
Renal / kidney
1
Other clinical outcomes
1
Other (unclassified)
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Bodyweight

Time frame:76 weeks

Body weight, % change

percent change from baseline, improvement

Other/protocol endpoint

Fat mass: fat free mass ratio

Time frame:76 weeks

ratio, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

HbA1c

Time frame:76 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time in range

Time frame:76 weeks

CGM time-in-range

change from baseline, improvement

MASH / liver

1 endpoint
Other/protocol endpoint

Liver stiffness

Time frame:76 weeks

change from baseline, improvement

Renal / kidney

1 endpoint
Other/protocol endpoint

Kidney Disease: Improving Global Outcomes (KDIGO) score for Diabetic nephropathy

Time frame:76 weeks

categorical status, improvement

componentseGFR, change, uACR, change

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Systolic Blood pressure

Time frame:76 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic Blood pressure

Time frame:76 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Total cholesterol

Time frame:76 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

HDL

Time frame:76 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Triglycerides

Time frame:76 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

LDL

Time frame:76 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

CRP

Time frame:76 week

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

SF-36 (36-Item Short Form Survey) for Quality of life

Time frame:76 weeks

SF-36 total

descriptive, improvement

Other/protocol endpoint

Functional improvements in quality of life

Time frame:76 weeks

SF-36 physical

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Time in hypoglycaemia

Time frame:76 weeks

change from baseline, event

Other/protocol endpoint

Incidence of treatment emergent events

Time frame:76 weeks

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

1 endpoint
Other/protocol endpoint

Diabetic Retinopathy Severity Scale (DRSS)

Time frame:76 weeks

descriptive, improvement

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Diastolic cardiac function on MRI

Time frame:76 weeks

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.