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A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes

Plain-language guide to NCT07668388: phase 2 randomized trial of Semaglutide, 300 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07668388
Phase
phase 2
Status
recruiting participants
Start
2026-06-22
Completion (planned or actual)
2027-10-04
Participants
300 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Diabetes Mellitus, Type 2
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

The study is testing UBT251 in participants with type 2 diabetes.

Participants will either get UBT251, UBT251 placebo, semaglutide, or semaglutide placebo.

It had four arms (groups): UBT251 (experimental), UBT251 Placebo (placebo comparator), Semaglutide (active comparator) and Semaglutide Placebo (placebo comparator).

Participants will receive once weekly UBT251 subcutaneously.

Participants will receive once weekly UBT251 placebo subcutaneously.

Participants will receive once weekly semaglutide subcutaneously.

The registry classes the interventions as drug.

Who Took Part

The registry lists 300 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: known hypoglycaemic unawareness as indicated by the investigator according to clarke's questionnaire, question 8.

How the Study Was Run

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

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

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

It started in 2026-06-22 with completion listed for 2027-10-04.

It ran at 70 sites in United States (25), Germany (8), Australia (6), Poland (6), Romania (6) and Spain (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: UBT251: Change in glycated haemoglobin (HbA1c).

It also tracked 24 secondary outcomes, for example UBT251: Relative change in body weight, UBT251: Change in body weight, UBT251 vs placebo: Change in HbA1c, Change in HbA1c, Change in homeostasis model assessment of insulin resistance (HOMA2-IR) and Change in homeostasis model assessment of beta-cell function (HOMA2-B).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 300 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.

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.