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A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

NCT04228354 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-01-10

No results posted yet for this study

Summary

The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Conditions

Interventions

DRUG

Semaglutide

Two doses of semaglutide given by subcutaneous (s.c., under the skin) injection with different drug product concentration and separated by 6 to 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor & Disclosure (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2020-06-01
Completion
2020-06-01

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT04228354 on ClinicalTrials.gov