← Human Trials & Peer-Reviewed Studies

Semaglutide Treatment in Type 1 Diabetes

Plain-language guide to NCT06909006: phase 3 randomized trial of Semaglutide, fat loss, obesity & body recomposition, 122 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06909006
Phase
phase 3
Status
not yet recruiting
Start
2025-10
Completion (planned or actual)
2028-06
Participants
122 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Obesity in Diabetes; Obesity/Therapy; Type 1 Diabetes Mellitus (T1DM); Insulin Sensitivity/Resistance; Semaglutide; Lipidomics
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Semaglutide for fat loss, obesity & body recomposition and insulin resistance, prediabetes & type 2 diabetes.

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

Visually identical injector pen without the active comparator.

The registry classes the interventions as drug.

More on the Plan

If accepted, the patients will be randomised to one of two intervention arms and undergo a series of different examinations prior to start of the intervention.

The two arms consist of treatment with subcutaneous semaglutide injections or subcutaneous injections with semaglutide placebo.

Fib-4-scoring, hematology, hsCRP), ECG, capturing of data from continuous/flash glucose monitors.

Patients will then be handed out their trial drug-pens and start the uptitration proces.

Who Took Part

122 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: BMI ≥ 30 or ≥ 27 and atleast one comorbidity (hypertension, hypercholesterolemia, microalbuminuria, ischemic heart disease, history of stroke, atherosclerosis or arthrosis.

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: treated with glp1-ras within last 6 months; known intolerance for semaglutide; pregnant or nursing women.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-10 with completion listed for 2028-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Body weight (time frame: 74 weeks).

It also tracked 42 secondary outcomes, for example Systolic blood pressure, Diastolic blood pressure, Resting heart rate, Waist circumference, Hip-waist-ratio and Hemoglobin.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 122 people with fat loss, obesity & body recomposition.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research, Insulin resistance, prediabetes & type 2 diabetes research.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.