Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment

What Was Tested

The trial (phase 2) is built around Semaglutide.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

Participants in this arm will receive a matched placebo weekly for 12 months. Then a 4 week wean period plus 2 weeks as needed insulin titration.

The registry classes the interventions as drug.

More on the Plan

This is a single-center, parallel group, double-blinded, placebo controlled, randomized clinical trial.

At 52 weeks, participants will repeat the baseline tests.

They will then complete a wean off of study drug (up to 4 weeks) and 2 weeks of additional monitoring for insulin titration.

Who Took Part

54 planned participants were the target.

It was open to people of any sex aged from 18 years up to 30 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Clinical diagnosis of T1D. Ability to provide written informed consent before any trial-related activities. Use of real-time continuous glucose monitoring and planned continued use. Stated willingness to comply with all study procedures, medication regimen, and availability for the duration of the study. Participants cannot be randomized if any laboratory safety parameter at screening is outside the below extended laboratory ranges. For randomization, participants should have.

The full record lists 14 inclusion and 18 exclusion criteria; among the exclusions: current psychiatric conditions impacting weight, including known eating disorders; contraindications to study medications, including:; personal history of pancreatitis, renal impairment, or known liver disease other than non-alcoholic hepatic steatosis.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and care provider.

It started in 2024-07-16 with completion listed for 2028-04-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in VAT/(VAT+SAT) from baseline to 12 months (time frame: baseline and 12 months). Change in hepatic insulin resistance from baseline to 12 months (time frame: baseline and 12 months). Change in triglycerides from baseline to 12 months (time frame: baseline and 12 months).

It also tracked 7 secondary outcomes, for example Change in weight from baseline to 12 months, Change in percent body fat from baseline to 12 months, Change in BMI from baseline to 12 months, Change in mean glucose concentration, Mean time in normal glucose range and Mean time in level 1 and 2 hyperglycemia, high range.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 54 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.