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Phase 2CompletedNCT05537233

ADJUST-T1D: semaglutide with AID in adults with obesity

What this study tests

A 26-week randomized trial in 72 adults with T1D, obesity and automated insulin delivery found that semaglutide improved a combined glucose-and-weight endpoint versus placebo.

Editorial review: . What was checked and what remains uncertain.

Registry checked: 2026-09-16. Registry’s own update: 2025-09-03.

Latest dated source in the citation list: 2025-06-23. This is the source’s date, not a new review of every claim.

Trial status, labels and access can change between reviews.

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Adults aged 18–65 with T1D for at least 12 months, BMI at least 30 kg/m², HbA1c above 7% and below 10%, and an approved hybrid closed-loop system for at least three months. Recent DKA and severe hypoglycemia were exclusions. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
The combined target (time in 70–180 mg/dL above 70%, time below 70 mg/dL under 4%, and at least 5% weight loss) was reached by 36% on semaglutide versus 0% on placebo. Between-group differences at 26 weeks were +8.8 percentage points in time in range and −8.8 kg in weight. Each group had two severe hypoglycemia events; no DKA was reported. These short-term findings in a selected adult population do not establish safety for all people with T1D.[^paper]Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read this trial’s review notes for the checks completed and what remains unresolved. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • 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 — 26 weeks

The full picture

What the study asks

A 26-week randomized trial in 72 adults with T1D, obesity and automated insulin delivery found that semaglutide improved a combined glucose-and-weight endpoint versus placebo.

Who it involves

Adults aged 18–65 with T1D for at least 12 months, BMI at least 30 kg/m², HbA1c above 7% and below 10%, and an approved hybrid closed-loop system for at least three months. Recent DKA and severe hypoglycemia were exclusions. This is a summary; the full registry lists additional criteria.1

Design and timing

The registry lists 115 participants (actual enrollment). Primary completion: 2024-08-06 (actual). Study completion: 2024-08-06 (actual). Estimated dates can change and do not mean results are available.1

Evidence and limits

The combined target (time in 70–180 mg/dL above 70%, time below 70 mg/dL under 4%, and at least 5% weight loss) was reached by 36% on semaglutide versus 0% on placebo. Between-group differences at 26 weeks were +8.8 percentage points in time in range and −8.8 kg in weight. Each group had two severe hypoglycemia events; no DKA was reported. These short-term findings in a selected adult population do not establish safety for all people with T1D.2

The publication and posted participant flow both report 72 randomized participants (36 per arm). The registry header lists 115 actual enrollment; this is not the randomized denominator used for the results above. Semaglutide was titrated to at most 1 mg weekly in this study; this is a study description, not dosing advice.

References

  1. ClinicalTrials.gov. NCT05537233. Record checked 16 September 2026; last update posted 2025-09-03. https://clinicaltrials.gov/study/NCT05537233 ↩ ↩2

  2. Shah VN et al. Semaglutide in Adults with Type 1 Diabetes and Obesity. NEJM Evidence, published 23 June 2025. https://pubmed.ncbi.nlm.nih.gov/40550013/ ↩

Sources

  1. [1]ADJUnct Semaglutide Treatment in Type 1 Diabetes (NCT05537233) · registry — Protocol and current registry status checked 16 September 2026.
  2. [2]Semaglutide in Adults with Type 1 Diabetes and Obesity · peer-reviewed · 2025-06-23