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A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People

NCT05227196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 546

Last updated 2024-09-19

No results posted yet for this study

Summary

The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.

The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.

The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).

Conditions

Interventions

DRUG

Semaglutide D Dose 1

Tablet given orally

DRUG

Semaglutide D Dose 2

Tablet given orally

DRUG

Semaglutide D Dose 3

Tablet given orally

DRUG

Semaglutide Dose 4

Tablet given orally

DRUG

Semaglutide Dose 5

Tablet given orally

DRUG

Semaglutide Dose 6

Tablet given orally

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (Dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-04
Primary Completion
2023-06-28
Completion
2023-08-08
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05227196 on ClinicalTrials.gov