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SEMA SMA

RecruitingPhase 2, PHASE3

Alleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide

Alleviating Carbohydrate Counting Using Weekly Subcutaneous Semaglutide Injections in People with Type 1 Diabetes on Closed-Loop Insulin Therapy: a 2x4 Factorial Randomized Placebo-Controlled Trial

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

26

estimated

Study population

Type 1 diabetes

Key I/E criterion

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 IDNCT06387199
Org study ID2024-10227

Timeline

Milestones

Study first posted2024-04-26actual
Study start2024-12-01actual
Last update posted2024-12-18actual
Primary completion2027-01estimated (month precision)
Study completion2027-01estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. At least 18 years of age

2. A clinical diagnosis of T1D for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical judgment (confirmatory C-peptide and antibodies will not be required)

3. Minimum 3-month use of a commercial advanced automated insulin delivery system. 4.4. Agreement to use an effective method of birth control for individuals with child-bearing potential. Child-bearing 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

1. Use of GLP1-RAs within the last 4 weeks.

2. Use of any anti-hyperglycemic agent other than insulin within the last 2 weeks.

3. Planned or ongoing pregnancy

4. Breastfeeding

5. Severe hypoglycemic episode within the last 3 months, defined as an event where glucose was < 4 mmol/L resulting in seizure, loss of consciousness, or need to present to the emergency department

6. Severe diabetic ketoacidosis (DKA) within the last 6 months ("severe" referring to need to present to medical attention and requirement of intravenous insulin)

7. Prior history of acute pancreatitis, chronic pancreatitis, or gallbladder disease

8. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

9. Severe impairment of renal function with eGFR <30 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months

10. Clinically significant diabetic retinopathy or gastroparesis, as per the clinical judgment of the investigator

11. Bariatric surgery within the last 6 months.

12. A serious medical or psychiatric illness that is likely to interfere with study participation as per the judgment of the investigator (e.g. cirrhosis, active cancer, decompensated schizophrenia).

13. Body mass index ≤ 21 kg/m2

14. Inability or unwillingness to comply to safe diabetes management in the view of the study group (e.g. inappropriate treatment of hypoglycemia or lack thereof)

15. Concern for safety of the participant, as per the clinical judgment of the primary investigator

Endpoints (21)

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
10
Weight & body composition
4
Cardiometabolic biomarkers
3
Patient-reported / QoL
3
Renal / kidney
1

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Measure of body weight

Time frame:24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Measure of body mass index

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

Measure of waist circumference and hip circumference

Time frame:24 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Measure of waist-to-hip ratio

Time frame:24 weeks

ratio, improvement

Glycemic / diabetes

10 endpoints
Primary/protocol endpoint

Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo)

Time frame:24 weeks

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Percentage of time spent in the range of glucose levels between 3.9 and 7.8 mmol/L

Time frame:24 weeks

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of time spent in glucose levels below 3.9 and 3.0 mmol/L

Time frame:24 weeks

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of time spent in glucose levels above 7.8, 10 and 13.9 mmol/L

Time frame:24 weeks

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Mean glucose level

Time frame:24 weeks

descriptive, improvement

Secondary/protocol endpoint

Standard deviation of glucose levels as a measure of glucose variability

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Percentage coefficient of variation of glucose levels

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

Proportions of participants with time in range between 3.9 - 10.0 mmol/L≥ 70%

Time frame:24 weeks

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Glycated hemoglobin (HbA1c)

Time frame:24 weeks

descriptive

LOINC 4548-4

Secondary/protocol endpoint

Area under the curve 0-2h post meal, 0-3h post peal

Time frame:24 weeks

descriptive

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Urine albumin-creatinine ratio

Time frame:24 weeks

uACR, change

ratio, improvement

LOINC 9318-7

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Heart rate

Time frame:24 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Blood pressure

Time frame:24 weeks

descriptive, improvement

Secondary/protocol endpoint

Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides

Time frame:24 weeks

change from baseline, improvement

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint/low confidence

Average scores between interventions on the Type 1 Diabetes Distress Scale questionnaire

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

Average scores between interventions on the Diabetes Treatment Satisfaction questionnaire

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Average scores between interventions based on the Hypoglycemic Fear Survey - II

Time frame:24 weeks

descriptive, improvement

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.