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

Part of paid clinical trials in Cypress, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT05227196
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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).

Key Dates

First listed
Feb 7, 2022
Start date
Feb 4, 2022
Status verified
Sep 2024
Primary completion
Jun 28, 2023
Completion
Aug 8, 2023

Study Design

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

Arms

  • Experimental: Group 1 Sequence 1
    Crossover arm
  • Experimental: Group 1 Sequence 2
    Crossover arm
  • Experimental: Group 2 Sequence 1
    Crossover arm
  • Experimental: Group 2 Sequence 2
    Crossover arm
  • Experimental: Group 3 Sequence 1
    Crossover arm
  • Experimental: Group 3 Sequence 2
    Crossover arm

Primary Outcome Measure

AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS) [ Time Frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Altasciences Clinical LA, Inc.CypressCalifornia90630-
Altasciences Clinical Kansas, Inc.Overland ParkKansas66212-

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By research site
Altasciences Clinical LA, Inc.· Cypress, CAAltasciences Clinical Kansas, Inc.· Overland Park, KS

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