DelfaGLP-1 Atlas

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OBES1TY

Not yet recruitingPhase 3

Semaglutide Treatment in Type 1 Diabetes

Obesity and Semaglutide in Type 1 Diabetes Therapy: A Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

122

estimated

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT06909006
Org study IDU1111-1304-0713

Timeline

Milestones

Study first posted2025-04-03actual
Last update posted2025-08-08actual
Study start2025-10estimated (month precision)
Primary completion2028-06estimated (month precision)
Study completion2028-06estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Type 1 Diabetes for more than 3 years
•BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis

Exclusion criteria

•Treated with GLP1-RAs within last 6 months
•Known intolerance for semaglutide
•Other forms of diabetes
•Pregnant or nursing women
•Fertile women not using chemical (hormonal) or mechanical (spiral) contraceptives
•Liver disease with elevated plasma alanine aminotransferase (ALT) > five times and plasma aspartate aminotransferase (AST) > five times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
•Acute or chronic pancreatitis
•Cancer, unless in complete remission for > 5 years or unless basocellular carcinomas
•History of thyroid adenoma or carcinoma
•Alcohol/drug abuse
•Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
•Receipt of an investigational drug within 30 days prior to visit 0 / Simultaneous participation in any other clinical intervention trial

Endpoints (47)

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
11
Glycemic / diabetes
10
Other (unclassified)
7
Weight & body composition
6
Safety / tolerability / PK
6
MASH / liver
3
Patient-reported / QoL
3
Renal / kidney
1

Weight & body composition

6 endpoints
Primary/protocol endpoint

Body weight

Time frame:74 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:74 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Hip-waist-ratio

Time frame:74 weeks

change from baseline, improvement

Secondary/protocol endpoint

Fat percentage

Time frame:68 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Lean mass

Time frame:68 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Bone density (through bone mineral content)

Time frame:68 weeks

change from baseline, descriptive

Glycemic / diabetes

10 endpoints
Secondary/protocol endpoint

HbA1c

Time frame:74 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting plasma-glucose

Time frame:74 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Fasting c-peptide

Time frame:74 weeks

change from baseline, improvement

Secondary/protocol endpoint

CGM data - Time in range (TIR)

Time frame:68 weeks

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

CGM data - Time in tight range (TITR)

Time frame:68 weeks

change from baseline, improvement

Secondary/protocol endpoint

CGM data - Time above range (TAR)

Time frame:68 weeks

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

CGM data - Time below range (TBR)

Time frame:68 weeks

CGM time-below-range

change from baseline, improvement

Secondary/protocol endpoint/low confidence

CGM data - coefficient of variation (CV)

Time frame:68 weeks

change from baseline, improvement

Secondary/protocol endpoint

Total daily dose of insulin

Time frame:74 weeks

change from baseline, improvement

Secondary/protocol endpoint

Insulin sensitivity

Time frame:68 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

3 endpoints
Secondary/protocol endpoint

Alanine transaminase (ALT)

Time frame:74 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Aspartate transaminase (AST)

Time frame:74 weeks

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Fibrosis-4-score (Fib-4)

Time frame:74 weeks

change from baseline, improvement

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Creatinine/eGFR

Time frame:74 weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

11 endpoints
Secondary/protocol endpoint

Systolic blood pressure

Time frame:74 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic blood pressure

Time frame:74 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Resting heart rate

Time frame:74 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Total cholesterol

Time frame:74 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

HDL cholesterol

Time frame:74

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

LDL cholesterol

Time frame:74 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

VLDL cholesterol

Time frame:74 weeks

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Triglycerides

Time frame:74 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

non-HDL cholesterol

Time frame:74 weeks

Non-HDL cholesterol, change

change from baseline, improvement

Secondary/protocol endpoint

High sensitivity C-reactive protein (hsCRP)

Time frame:74 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint/low confidence

Ketones

Time frame:74 weeks

change from baseline, descriptive

Patient-reported / QoL

3 endpoints
Other/protocol endpoint

Patient reported outcome measures - Dietary patterns

Time frame:74 weeks

descriptive

Other/protocol endpoint

Patient reported outcome measures - Diabetes treatment satisfaction

Time frame:74 weeks

change from baseline, improvement

Other/protocol endpoint

Patient reported outcome measures - Diabetes distress

Time frame:74 weeks

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Thrombocytes

Time frame:74 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Potassium

Time frame:74 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Amylase

Time frame:74 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Lipase

Time frame:74 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Electrocardiogram

Time frame:68 weeks

descriptive

Other/protocol endpoint

Adverse events

Time frame:74 weeks

Treatment-emergent AEs (any)

descriptive

Other (unclassified)

7 endpoints
Secondary/protocol endpoint/low confidence

Hemoglobin

Time frame:74 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Leucocytes

Time frame:74 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Sodium

Time frame:74 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Albumin

Time frame:74 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Omics / Metabolome

Time frame:74 weeks

descriptive

Secondary/protocol endpoint/low confidence

Muscle tissue biopsy

Time frame:68 weeks

descriptive

Secondary/protocol endpoint/low confidence

Fat tissue biopsy

Time frame:68 weeks

descriptive

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.