Semaglutide for Type 1 Diabetes
(ADJUST-T1D Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byViral N Shah, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Viral N. Shah

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for obese adults over 18 with type 1 diabetes using FDA-approved hybrid closed-loop systems for at least 3 months. Participants should have a BMI ≥30 kg/m2, HbA1c levels between >7.0% and <10.0%, and be willing to take weekly semaglutide injections. Excluded are those planning pregnancy, with certain medical conditions or severe hypoglycemia history, on other trials or specific medications.

Inclusion Criteria

Willing to share devices (HCL system) data uploads

You have a body mass index (BMI) of 30 or higher.

You currently have a device to measure ketones in your body.

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Exclusion Criteria

I have been diagnosed with gastroparesis or a stomach emptying disorder.

I have had cancer treatment within the last 5 years.

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

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Treatment Details

Interventions

Placebo (Other)
Semaglutide (Glucagon-like peptide-1 receptor agonist)

Trial OverviewThe study tests the effectiveness of semaglutide, a once-weekly injection, in controlling blood sugar in obese adults with poorly managed type 1 diabetes who are already using approved automated insulin delivery systems.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention

Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy

Group II: ControlPlacebo Group1 Intervention

Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy