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A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens

NCT04152915 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-11-10

No results posted yet for this study

Summary

The study will look at how two different semaglutide versions reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. Participants will get 1 of the 2 versions of semaglutide. Which version participants get is decided by chance. One version is the one that doctors already can prescribe and the other is the new version. Participants will get the medicines as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two versions of semaglutide. The study will last for about 80-99 days. Participants will have 24 study visits with the study doctor. For 2 of the 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

  • Healthy Volunteers
  • Diabetes Mellitus, Type 2

Interventions

DRUG

Semaglutide

Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2020-05-25
Completion
2020-05-25

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT04152915 on ClinicalTrials.gov