Semaglutide in Auto-HSCT

What Was Tested

The trial (phase 2) is built around Semaglutide.

Study design: The study is designed as a randomized, double-blind, placebo-controlled, phase 2, two-centre investigator-initiated clinical study.

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

Semaglutide placebo, once-weekly, injection.

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 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: Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma or follicular lymphoma. Age ≥ 18 years. BMI ≥ 18.5. ECOG performance status\* ≤ 2. Literate in Danish and/or English.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: inflammatory bowel disease; previous or current gastrointestinal malignancy; personal or family history of medullary thyroid carcinoma or men syndrome.

How the Study Was Run

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

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.

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 2024-08-12 with completion listed for 2026-12-31.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): gastrointestinal mucositis severity (time frame: from day of stem cell infusion (day 0) to week +3).

It also tracked 4 secondary outcomes, for example CRP increment, Quality of life general and Safety profile evaluated by number of SARs.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 40 people.

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, all human trials.