ADJUST-T1D

CompletedPhase 2Results posted

ADJUnct Semaglutide Treatment in Type 1 Diabetes

Efficacy and Safety of Once Weekly Semaglutide in Adults With Obesity and Inadequately Controlled Type 1 Diabetes Using Hybrid Closed-Loop System.

Lead sponsor

Viral N. Shah

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

115

actual

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criteria

•BMI ≥30•HbA1c 7-10%

Primary endpoint

•Proportion of Adults With T1D Achieving Composite Outcome>70% With Time Below (CGM time-in-range, CGM time-below-range, ≥5% weight-loss responders)

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 IDNCT05537233

Org study ID22388

Timeline

Milestones

Study first posted2022-09-13actual

Study start2023-04-11actual

Primary completion2024-08-06actual

Study completion2024-08-06actual

Results first posted2025-08-12actual

Last update posted2025-09-03actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

For an eligible subject, all inclusion criteria must be answered "yes"

1. Age ≥18 and ≤ 65 years

2. Patients with clinical diagnosis of T1D diagnosed for at least 12 months

3. Patient is on FDA- approved hybrid closed-loop system for ≥ 3 months

4. Willing to use once weekly semaglutide

5. Willing to share devices (HCL system) data uploads

6. HbA1c >7.0% and <10.0%

7. Body mass index ≥30 kg/m2

8. Has current glucagon product to treat severe hypoglycemia

9. Has current ketone meters to check ketones

10. Ability to provide informed consent before any trial-related activities

Exclusion criteria

1. Age <18 years and >65 years

2. HbA1c ≤7.0 % or ≥ 10.0% at screening

3. Less than 12 months of insulin treatment

4. Use of unapproved insulin for HCL system. E.g. use of Fiasp in the Tandem Control-IQ system

5. Not willing to share the devices (HCL system) data uploads

6. Non compatible devices (e.g. pump, CGM or smart phones) for data transfer

7. Current use of multiple daily injection or inhaled insulin (Afrezza)

8. Patients with T1D using any glucose lowering medications other than insulin at the time of screening

9. Pregnancy, breast feeding, and positive pregnancy test during screening

10. Women of childbearing age wanting to become pregnant

11. Unwilling to use acceptable contraceptive methods (for both men and women) during the trial period

12. Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (>4 weeks continuously), during the study period

13. Use of GLP-1RA or weight loss medications in the past 3 month

14. Clinical diagnosis/history of gastroparesis or gastric motility disorders

15. Serum triglycerides >500 mg/dL

16. Planning for bariatric surgery during the study period

17. eGFR below 45 ml/min/1.73 m^2 using CKD-EPI formula

18. History of severe hypoglycemia in the previous 3 months

19. History of diabetic ketoacidosis requiring hospitalization in the past 3 months

20. History of allergy to any form of insulin, GLP-1RA or its excipients

21. History of any form of pancreatitis

22. History of stroke, myocardial infarction in the past 3 months

23. History of congestive heart failure class III or IV

24. History of acute or chronic liver disease

25. History of malignancy requiring chemotherapy, surgery or radiation in previous 5 years

26. Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or familial thyroid carcinoma or non-familial medullary thyroid carcinoma

27. Have a pacemaker, metal implants, or aneurysm clips or weigh >330 lbs (exclusion only if doing MRI)

28. Use of investigational drugs within 5 half-lives prior to screening

29. Participation to other intervention trials during the study period

30. Any comorbidities or medical conditions such as severe psychiatric disorder that make a person unfit for the study at the discretion of the investigators

Endpoints (110)

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

Cardiometabolic biomarkers

Other (unclassified)

Weight & body composition

Renal / kidney

MASH / liver

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

12 endpoints

Secondary/registry result

Change in Weight

Time frame:26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Semaglutide	-9.2	—
Control	-0.4	—

Secondary/registry result

Change in BMI (Kg/m2)

Time frame:26 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg/m2	95% CI
Semaglutide	-3.3	—
Control	-0.2	—

Secondary/protocol endpoint

Change in Weight

Time frame:26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI (Kg/m2)

Time frame:26 weeks

BMI, change

change from baseline, improvement

Other/protocol endpoint

Proportion Achieving Weight Loss ≥5%

Time frame:26 weeks

≥5% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Proportion Achieving Weight Loss ≥10%

Time frame:26 weeks

≥10% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Proportion of Achieving BMI <30 kg/m2

Time frame:26 weeks

threshold achievement, improvement

Other/protocol endpoint

Proportion of Achieving BMI <25 kg/m2

Time frame:26 weeks

threshold achievement, improvement

Other_pre_specified/registry result

Proportion Achieving Weight Loss ≥5%

Time frame:26 weeks

≥5% weight-loss responders

threshold achievement, improvement

Other_pre_specified/registry result

Proportion Achieving Weight Loss ≥10%

Time frame:26 weeks

≥10% weight-loss responders

threshold achievement, improvement

Other_pre_specified/registry result

Proportion of Achieving BMI <30 kg/m2

Time frame:26 weeks

threshold achievement, improvement

Other_pre_specified/registry result

Proportion of Achieving BMI <25 kg/m2

Time frame:26 weeks

threshold achievement, improvement

Glycemic / diabetes

40 endpoints

Secondary/registry result

Change in HbA1c

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage HbA1c	95% CI
Semaglutide	-0.7	—
Control	-0.4	—

Secondary/registry result/low confidence

Change in Mean Glucose

Time frame:26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Semaglutide	-15.7	—
Control	-3.6	—

Secondary/registry result

Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)

Time frame:26 weeks

CGM time-in-range

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of time	95% CI
Semaglutide	9.8	—
Control	2.9	—

Secondary/registry result

Percent Time Spent in CGM-measured Glucose >180 mg/dL

Time frame:26 weeks

CGM time-above-range

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage	95% CI
Semaglutide	-11.1	—
Control	-2.7	—

Secondary/registry result

Percent Time Spent in CGM-measured Glucose >250mg/dL

Time frame:26 weeks

CGM time-above-range

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage	95% CI
Semaglutide	-5.1	—
Control	-0.5	—

Secondary/registry result

Percent Time Spent in CGM-measured Glucose <70mg/dL

Time frame:26 weeks

CGM time-below-range

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage	95% CI
Semaglutide	0.1	—
Control	0.4	—

Secondary/registry result

Change in CGM Measured Glycemic Variability (Coefficient of Variation)

Time frame:26 weeks

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage	95% CI
Semaglutide	-0.3	—
Control	0.9	—

Secondary/protocol endpoint

Change in HbA1c

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Mean Glucose

Time frame:26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)

Time frame:26 weeks

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

Percent Time Spent in CGM-measured Glucose >180 mg/dL

Time frame:26 weeks

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Time Spent in CGM-measured Glucose >250mg/dL

Time frame:26 weeks

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Time Spent in CGM-measured Glucose <70mg/dL

Time frame:26 weeks

CGM time-below-range

threshold achievement, improvement

Secondary/protocol endpoint

Change in CGM Measured Glycemic Variability (Coefficient of Variation)

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint

Proportion of Participants With HbA1c <7%

Time frame:26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Other/protocol endpoint

Proportion of Participants With HbA1c <7.5%

Time frame:26 weeks

threshold achievement, improvement

LOINC 4548-4

Other/protocol endpoint

HbA1c Improvement

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

HbA1c Improvement of >0.4% From Baseline

Time frame:26 weeks

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Other/protocol endpoint

Proportion of Participants Achieving TIR >70%

Time frame:26 weeks

CGM time-in-range

threshold achievement, improvement

Other/protocol endpoint

Proportion of Participants Achieving TITR >50%

Time frame:26 weeks

CGM time-in-range

threshold achievement, improvement

Other/protocol endpoint

Proportion of Participants Achieving TIR >80%

Time frame:26 weeks

CGM time-in-range

threshold achievement, improvement

Other/protocol endpoint

Proportion of Participants Achieving TITR >60%

Time frame:26 weeks

threshold achievement, improvement

Other/protocol endpoint

Number of TBR<70 Events

Time frame:26 weeks

CGM time-below-range

event count, improvement

Other/protocol endpoint

Number of TBR <54 Events

Time frame:26 weeks

CGM time-below-range

event count, event

Other/protocol endpoint

Change in Total Daily Dose of Insulin (TDD, Units Per Day and U/Kg/Day)

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in CGM Metrics by Daytime vs Nighttime

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint

Change in Basal Insulin Per Day

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result

Proportion of Participants With HbA1c <7%

Time frame:26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Other_pre_specified/registry result

Proportion of Participants With HbA1c <7.5%

Time frame:26 weeks

threshold achievement, improvement

LOINC 4548-4

Other_pre_specified/registry result

HbA1c Improvement

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other_pre_specified/registry result

HbA1c Improvement of >0.4% From Baseline

Time frame:26 weeks

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Other_pre_specified/registry result

Proportion of Participants Achieving TIR >70%

Time frame:26 weeks

CGM time-in-range

threshold achievement, improvement

Other_pre_specified/registry result

Proportion of Participants Achieving TITR >50%

Time frame:26 weeks

CGM time-in-range

threshold achievement, improvement

Other_pre_specified/registry result

Proportion of Participants Achieving TIR >80%

Time frame:26 weeks

CGM time-in-range

threshold achievement, improvement

Other_pre_specified/registry result

Proportion of Participants Achieving TITR >60%

Time frame:26 weeks

CGM time-in-range

threshold achievement, improvement

Other_pre_specified/registry result

Number of TBR<70 Events

Time frame:26 weeks

CGM time-below-range

event count, event

Other_pre_specified/registry result

Number of TBR <54 Events

Time frame:26 weeks

CGM time-below-range

event count, event

Other_pre_specified/registry result/low confidence

Change in CGM Metrics by Daytime vs Nighttime

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in Basal Insulin Per Day

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in Total Bolus Insulin Per Day

Time frame:26 weeks

change from baseline, improvement

MASH / liver

4 endpoints

Other/protocol endpoint

Change in Fib-4 Score

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint

Change in HSI (Hepatic Steatosis Index)

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in Fib-4 Score

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in HSI (Hepatic Steatosis Index)

Time frame:26 weeks

change from baseline, improvement

Renal / kidney

8 endpoints

Other/protocol endpoint

Change in Urine Albumin to Creatinine Ratio (ACR)

Time frame:26 weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Other/protocol endpoint

Change in eGFR

Time frame:26 weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Other/protocol endpoint

Proportion With ACR <30 at 26 Weeks

Time frame:26 weeks

Albuminuria regression

threshold achievement, improvement

LOINC 9318-7

Other/protocol endpoint

Proportion With Change in ACR From >30 to <30

Time frame:26 weeks

Albuminuria regression

threshold achievement, improvement

LOINC 9318-7

Other_pre_specified/registry result

Change in Urine Albumin to Creatinine Ratio (ACR)

Time frame:26 weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Other_pre_specified/registry result

Change in eGFR

Time frame:26 weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Other_pre_specified/registry result

Proportion With ACR <30 at 26 Weeks

Time frame:26 weeks

Albuminuria regression

threshold achievement, improvement

LOINC 9318-7

Other_pre_specified/registry result

Proportion With Change in ACR From >30 to <30

Time frame:26 weeks

Albuminuria regression

threshold achievement, improvement

LOINC 9318-7

Cardiometabolic biomarkers

21 endpoints

Other/protocol endpoint

Change in Systolic Blood Pressure (SBP)

Time frame:26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other/protocol endpoint

Change in Diastolic Blood Pressure (DBP)

Time frame:26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Other/protocol endpoint

Change in Pulse Pressure

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint

Change in Triglyceride/HDL Ratio

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint

Change in Brach D

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint

Change in Carotid Intima Media Thickness (cIMT)

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint

Change in Femoral to Carotid Pulse Wave Velocity (m/s)

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint

Change in LDL-C

Time frame:26 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Other/protocol endpoint

Change in TC

Time frame:26 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Other/protocol endpoint

Change in TG

Time frame:26 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other/protocol endpoint

Change in HDL-C

Time frame:26 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Other_pre_specified/registry result

Change in Systolic Blood Pressure (SBP)

Time frame:26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other_pre_specified/registry result

Change in Diastolic Blood Pressure (DBP)

Time frame:26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Other_pre_specified/registry result

Change in Pulse Pressure

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in Triglyceride/HDL Ratio

Time frame:26 weeks

ratio, improvement

Other_pre_specified/registry result

Change in Carotid Intima Media Thickness (cIMT)

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in Femoral to Carotid Pulse Wave Velocity (m/s)

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in LDL-C

Time frame:26 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Other_pre_specified/registry result

Change in TC

Time frame:26 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Other_pre_specified/registry result

Change in TG

Time frame:26 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other_pre_specified/registry result

Change in HDL-C

Time frame:26 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Patient-reported / QoL

4 endpoints

Other/protocol endpoint

Change in Patient Reported Quality of Life

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint

Quality of Life (Diabetes Dependent QOL)

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result

Change in Patient Reported Quality of Life

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result

Quality of Life (Diabetes Dependent QOL)

Time frame:26 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Severe Hypoglycemia

Time frame:26 weeks

Severe hypoglycemia

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide	2	—
Control	2	—

Secondary/protocol endpoint

Severe Hypoglycemia

Time frame:26 weeks

Severe hypoglycemia

event count, event

Other (unclassified)

19 endpoints

Primary/registry result/low confidence

Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group

Time frame:26 weeks

threshold achievement, improvement

componentsCGM time-in-range, CGM time-below-range, ≥5% weight-loss responders

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide	13	—
Control	0	—

Primary/protocol endpoint/low confidence

Time frame:26 weeks

threshold achievement, improvement

componentsCGM time-in-range, CGM time-below-range, ≥5% weight-loss responders

Other/protocol endpoint/low confidence

AID Setting Adjustment

Time frame:26 weeks

event count, descriptive

Other/protocol endpoint/low confidence

Change in Total Boluses Per Day

Time frame:26 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Achievement of Primary Outcome and Key Secondary Outcomes by Types of AID Systems

Time frame:26 weeks

threshold achievement, descriptive

Other/protocol endpoint/low confidence

Change in Carbohydrate Intake Per Day (Grams/Day)

Time frame:26 weeks

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in Total Bolus Insulin Per Day

Time frame:26 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in MRI Measured Pulse Wave Velocity and Longitudinal Strain

Time frame:26 weeks

change from baseline, improvement

componentspulse wave velocity, longitudinal strain

Other/protocol endpoint/low confidence

Achievement of Primary Outcomes by Baseline BMI (BMI <35 vs >35)

Time frame:26 weeks

descriptive

Other/protocol endpoint/low confidence

Achievement of Primary Outcomes by Baseline A1c (A1c <7.5% vs >7.5%)

Time frame:26 weeks

descriptive

Other_pre_specified/registry result/low confidence

Change in Total Daily Dose of Insulin (TDD, Units Per Day and U/Kg/Day)

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Change in Brach D

Time frame:26 weeks

change from baseline, improvement

Other_pre_specified/registry result/low confidence

AID Setting Adjustment

Time frame:26 weeks

event count, descriptive

Other_pre_specified/registry result/low confidence

Change in Total Boluses Per Day

Time frame:26 weeks

change from baseline, descriptive

Other_pre_specified/registry result/low confidence

Achievement of Primary Outcome and Key Secondary Outcomes by Types of AID Systems

Time frame:26 weeks

descriptive

Other_pre_specified/registry result/low confidence

Change in Carbohydrate Intake Per Day (Grams/Day)

Time frame:26 weeks

change from baseline, descriptive

Other_pre_specified/registry result/low confidence

Change in MRI Measured Pulse Wave Velocity and Longitudinal Strain

Time frame:26 weeks

change from baseline, improvement

componentspulse wave velocity, longitudinal strain

Other_pre_specified/registry result/low confidence

Achievement of Primary Outcomes by Baseline BMI (BMI <35 vs >35)

Time frame:26 weeks

descriptive

Other_pre_specified/registry result/low confidence

Achievement of Primary Outcomes by Baseline A1c (A1c <7.5% vs >7.5%)

Time frame:26 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

Semaglutide in Adults with Type 1 Diabetes and Obesity.
NEJM evidence2025 Aug (month)PMID40550013doi:10.1056/EVIDoa2500173via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.