A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

Status

Completed

Phase

Phase 1

Enrollment

36 participants (actual)

Sponsor

Novo Nordisk A/S · Industry

Design

Randomized · Quadruple masking

Countries

1 country

China

Start

21 Sept 2017

Primary completion

10 Jul 2018

Completion

7 Aug 2018

First posted

20 Sept 2017

Last update posted

15 Feb 2021

Conditions

Diabetes · Diabetes Mellitus, Type 2

The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way the drug is distributed in the body over a period of time) following once-weekly administration of semaglutide in healthy Chinese subjects. Different dose levels (0.5 and 1.0 mg) will be investigated in this trial. Participants will be administered semaglutide or placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall) using a pen injector with a very small, thin needle by the trial doctor at the trial site for 13 weeks. The trial consists of 23 visits in total, including visit for screening and safety tests, visit for dose administration and blood sample collection. The total time of participation will be approximately 18-22 weeks depending on participant's individual visit schedule.

• Experimental

  Semaglutide 0.5 mg

  Participants will enter a 13 weeks treatment with 4 weeks dosing at dose level 0.25 mg and 9 weeks at 0.5 mg semaglutide.

• Placebo comparator

  Semaglutide 0.5 mg placebo

  Participants will enter a 13 weeks treatment with 4 weeks dosing at dose level 0.25 mg and 9 weeks at 0.5 mg semaglutide placebo.

• Experimental

  Semaglutide 1.0 mg

  Participants will have 13 weeks treatment with 4 weeks dosing at dose level of 0.25 mg, 4 weeks at 0.5 mg, and 5 weeks at 1.0 mg semaglutide.

• Placebo comparator

  Semaglutide 1.0 mg placebo

  Participants will have 13 weeks treatment with 4 weeks dosing at dose level of 0.25 mg, 4 weeks at 0.5 mg, and 5 weeks at 1.0 mg semaglutide placebo.

1. Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg)

   Time frame · 0-168 hours after last administration of semaglutide

   Registry description

   Calculated based on semaglutide measured in blood.

2. Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg)

   Time frame · 0-168 hours after last administration of semaglutide

   Registry description

   Calculated based on semaglutide measured in blood.