A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese

Sponsor
Novo Nordisk A/S
Study ID
NCT04016974
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Oral semaglutide — DRUG
    Semaglutide tablets once daily as follows: 3 mg for the first treatment period (day 1-28), followed by 7 mg in the second treatment period (day 29-56), followed by 14 mg in the third treatment period (day 57-84)
  • Placebo — DRUG
    Placebo tablets once daily throughout the treatment period (day 1 to 84)

Study Details

This study looks at the way a new medicine tablet called semaglutide moves in and throughout the body over time. It will also look at if the medicine is safe and the body can accept it. The new medicine is planned to treat diabetes. The aim of the study is to see how semaglutide tablets work in healthy people who are Chinese. Participants will either get oral semaglutide tablets or placebo (dummy) tablets - which treatment is decided by chance. The tablet form of semaglutide is a new medicine that cannot be prescribed. Doctors can prescribe semaglutide as an injection only. It is for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 12 weeks (84 days). Participants will get 1 tablet a day to take with up to half a glass of water (maximum 120 mL). Participants must take the tablet first thing in the morning on an empty stomach (water is allowed until 2 hours before taking the tablet). After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After 30 minutes, they can have their first meal of the day and take any other medicines they may need, such as birth control tablets, routine vitamins and use of paracetamol at times.

Key Dates

Start date
Oct 8, 2019
Status verified
Jul 2024
Primary completion
Jan 23, 2021
Completion
Feb 26, 2021

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral semaglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

AUC0-24h,sema,SS, area under the semaglutide concentration-time curve during a dosing interval (0-24 hours) at steady state [ Time Frame: After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84 ]

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