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Could a weekly shot help people with type 1 diabetes lose weight and control blood sugar?

NCT ID NCT05537233

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a weekly injection of semaglutide (a drug used for type 2 diabetes and weight loss) in 115 adults with type 1 diabetes and obesity who already use an automated insulin pump. The goal was to see if adding semaglutide helps improve blood sugar levels, reduce hypoglycemia, and lower body weight. Participants received either semaglutide or a placebo for 26 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
semaglutide
What this could lead to
If successful, this could offer a new way to improve blood sugar control and reduce weight in people with type 1 diabetes who are overweight.
What could go wrong
This is a small, early-phase trial (Phase 2) with only 115 participants. Results may not apply to everyone, and semaglutide can cause side effects like nausea or vomiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

115 people

The number who actually took part.

Started

Apr 2023

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045, United States

  • Harold Schnitzer Diabetes Health Center

    Portland, Oregon, 97239, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Iowa Diabetes Research Center

    West Des Moines, Iowa, 50265, United States

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