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

Sponsor
Novo Nordisk A/S
Study ID
NCT04228354
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 29, 2020
Status verified
Jan 2022
Primary completion
Jun 1, 2020
Completion
Jun 1, 2020

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide 0.68 mg/mL
    Semaglutide administered with the PDS290 pen-injector
  • Experimental: Semaglutide 1.0 mg/mL
    Semaglutide administered with the PDS290 pen-injector

Primary Outcome Measure

Area under the semaglutide plasma concentration curve from 0 to tz [ Time Frame: 0-840 hours ]

Related Studies