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Type 1 DiabetesPhase 2ADJUST-T1DNCT05537233

ADJUnct Semaglutide Treatment in Type 1 Diabetes

A Phase 2 study testing Semaglutide in people with Type 1 Diabetes and Obesity, run by Viral N. Shah at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the use of once weekly semaglutide injection in inadequately controlled obese adults with type 1 diabetes (T1D) using FDA-approved hybrid closed-loop therapies. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes, Obesity
What is being tested?
Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
115 participants
Where
4 sitesUnited States
Study dates
11 Apr 2023to 6 Aug 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For an eligible subject, all inclusion criteria must be answered "yes"
  • Age ≥18 and ≤ 65 years
  • Patients with clinical diagnosis of T1D diagnosed for at least 12 months
  • Patient is on FDA- approved hybrid closed-loop system for ≥ 3 months
  • Willing to use once weekly semaglutide
  • Willing to share devices (HCL system) data uploads
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  • HbA1c >7.0% and <10.0%
  • Body mass index ≥30 kg/m2
  • Has current glucagon product to treat severe hypoglycemia
  • Has current ketone meters to check ketones
  • Ability to provide informed consent before any trial-related activities

Who cannot join

  • Age <18 years and >65 years
  • HbA1c ≤7.0 % or ≥ 10.0% at screening
  • Less than 12 months of insulin treatment
  • Use of unapproved insulin for HCL system. E.g. use of Fiasp in the Tandem Control-IQ system
  • Not willing to share the devices (HCL system) data uploads
  • Non compatible devices (e.g. pump, CGM or smart phones) for data transfer
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  • Current use of multiple daily injection or inhaled insulin (Afrezza)
  • Patients with T1D using any glucose lowering medications other than insulin at the time of screening
  • Pregnancy, breast feeding, and positive pregnancy test during screening
  • Women of childbearing age wanting to become pregnant
  • Unwilling to use acceptable contraceptive methods (for both men and women) during the trial period
  • Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (>4 weeks continuously), during the study period
  • Use of GLP-1RA or weight loss medications in the past 3 month
  • Clinical diagnosis/history of gastroparesis or gastric motility disorders
  • Serum triglycerides >500 mg/dL
  • Planning for bariatric surgery during the study period
  • eGFR below 45 ml/min/1.73 m^2 using CKD-EPI formula
  • History of severe hypoglycemia in the previous 3 months
  • History of diabetic ketoacidosis requiring hospitalization in the past 3 months
  • History of allergy to any form of insulin, GLP-1RA or its excipients
  • History of any form of pancreatitis
  • History of stroke, myocardial infarction in the past 3 months
  • History of congestive heart failure class III or IV
  • History of acute or chronic liver disease
  • History of malignancy requiring chemotherapy, surgery or radiation in previous 5 years
  • Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or familial thyroid carcinoma or non-familial medullary thyroid carcinoma
  • Have a pacemaker, metal implants, or aneurysm clips or weigh >330 lbs (exclusion only if doing MRI)
  • Use of investigational drugs within 5 half-lives prior to screening
  • Participation to other intervention trials during the study period
  • Any comorbidities or medical conditions such as severe psychiatric disorder that make a person unfit for the study at the discretion of the investigators

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Harold Schnitzer Diabetes Health Center

    Portland, Oregon, 97239

  • Iowa Diabetes Research Center

    West Des Moines, Iowa, 50265

Other trials in United States

About this study

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

The purpose of this study is to assess the use of once weekly semaglutide injection in inadequately controlled obese adults with type 1 diabetes (T1D) using FDA-approved hybrid closed-loop therapies.

Read the detailed description

After being informed about the study and potential risks, all patients given written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner using computer generated randomization scheme to receive either semaglutide or placebo (1:1 ratio) for 26 weeks.

Being tested
Semaglutide, Placebo
Keywords
Type 1 diabetes, Obesity, HbA1c, Time-in-range, Weight loss, Cardiovascular risk
Medical subject headings
Diabetes Mellitus, Type 1, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Semaglutide up to 1 mg per week in addition to standard closed-loop therapy

  • PlaceboDrug

    Injection placebo up to 1 mg per week in addition to standard closed-loop therapy

Study groups in NCT05537233
Study groupRoleWhat they receive
SemaglutideExperimentalParticipants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy
Receives: Drug: Semaglutide
ControlPlacebo comparatorParticipants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Primary outcome will be analyzed per statistical analysis plan using intention to treat basis.

    Measured: 26 weeks

Secondary outcomes (10)

  1. Change in HbA1c

    HbA1c will be measured at a central laboratory and change in Hba1c from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.

    Measured: 26 weeks

  2. Change in Mean Glucose

    Mean glucose (mg/dL) will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.

    Measured: 26 weeks

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

    Percent of time spent in tight glucose range (70-140 mg/dL) will be obtained by CGM and change in percent time in range from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.

    Measured: 26 weeks

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

    Percent of time spent in glucose range >180 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.

    Measured: 26 weeks

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

    Percent of time spent in glucose range >250 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.

    Measured: 26 weeks

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

    Percent of time spent in glucose range <70 mg/dL will be obtained by CGM and change in mean CGM glucose from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.

    Measured: 26 weeks

  7. Change in CGM Measured Glycemic Variability (Coefficient of Variation)

    Glucose coefficient of variation (mg/dL) will be obtained by CGM and change in glucose CV from baseline to 26 weeks will be compared by randomization group using intention to treat (ITT) analysis.

    Measured: 26 weeks

  8. Change in Weight

    The change in kg of body weight from baseline to 26 weeks will be compared by randomization group using an ITT analysis.

    Measured: 26 weeks

  9. Change in BMI (Kg/m2)

    Change in body mass index (BMI) calculated as kg body weight per meter squared of height from baseline to 26 weeks will be compared by randomization group using an ITT analysis.

    Measured: 26 weeks

  10. Severe Hypoglycemia

    SH events in number of patients per group

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start11 Apr 2023
  3. Primary completion6 Aug 2024
  4. Study completion6 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05537233
Sponsor's protocol ID
22388
Acronym
ADJUST-T1D
Status last verified
Aug 2025
First submitted
23 Aug 2022
Last updated
3 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: IPD may be available once the study is completed and all results are published.

Publications

  • Shah VN, Akturk HK, Kruger D, Ahmann A, Bhargava A, Bakoyannis G, Pyle L, Snell-Bergeon JK. Semaglutide in Adults with Type 1 Diabetes and Obesity. NEJM Evid. 2025 Aug;4(8):EVIDoa2500173. doi: 10.1056/EVIDoa2500173. Epub 2025 Jun 23.

    PubMed 40550013

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semaglutide in people with Type 1 Diabetes and Obesity, run by Viral N. Shah at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05537233, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.

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