Effect of an adjunctive intervention on the tolerability of semaglutide in overweight adults without diabetes: a prospective, randomised, double-blind, single-centre, placebo-controlled clinical trial (SEMTOL)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524612-11-00

Enrollment

100

Registered

2026-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and obesity

Brief summary

Semaglutide treatment tolerability operationalised as the severity of nausea measured using the 0–10 numeric rating scale (NRS) during the first 96 hours after semaglutide administration.

Detailed description

The period mean of the daily well-being according to numerical rating scale compared between treatment groups., Patient self-reported usage of daily oral study medication., Change in body weight from the baseline, Change in appetite, Incidence and severity of other side effects (vomiting, constipation, diarrhoea, abdominal pain, dizziness, fatigue, headache)

Interventions

DRUGRice flour

DRUGSEMAGLUTIDE

DRUGGRANISETRON

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Semaglutide treatment tolerability operationalised as the severity of nausea measured using the 0–10 numeric rating scale (NRS) during the first 96 hours after semaglutide administration.	—

Secondary

Measure	Time frame
The period mean of the daily well-being according to numerical rating scale compared between treatment groups., Patient self-reported usage of daily oral study medication., Change in body weight from the baseline, Change in appetite, Incidence and severity of other side effects (vomiting, constipation, diarrhoea, abdominal pain, dizziness, fatigue, headache)	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 22, 2026