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A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide

NCT05232708 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-01-26

No results posted yet for this study

Summary

In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2). Participants will receive 1 subcutaneous injection of semaglutide B (0.5 mg) and 1 subcutaneous injection of semaglutide D (0.5 mg). The trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. Participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. Participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (Day 1) in Period 1 and Period 2.

Conditions

  • Healthy Volunteers (Diabetes Mellitus, Type 2)

Interventions

DRUG

Semaglutide B, 1.34 mg/mL

Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.

DRUG

Semaglutide D, 1.0 mg/mL

Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.

DRUG

Semaglutide D, 1.0 mg/mL

Subjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.

DRUG

Semaglutide B, 1.34 mg/mL

Subjects will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.

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
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2022-08-30
Completion
2022-08-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT05232708 on ClinicalTrials.gov