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Completed

NCT Number: NCT03288740

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female Chinese subjects
  • Age between 18 to 55 years (both inclusive) at the time of signing informed consent
  • Body mass index (BMI) between 20 and 24.9 kg/sqm (both inclusive)
  • Body weight greater than or equal to 54.0 kg

Exclusion criteria

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods
  • Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
  • Use of prescription or non-prescription systemic products (including routine or non-routine vitamins or herbal products) or topical medicinal products (except paracetamol and oral contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (randomisation)
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  • History of pancreatitis (acute or chronic)
  • Calcitonin greater than or equal to 50 ng/L
  • Blood donation, surgery or trauma with significant blood loss (400 mL) within the last 12 weeks prior to screening

Treatment and study plan

Semaglutide 0.5 mg

Drug

A dose of 0.25 mg semaglutide gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.

Placebo (semaglutide 0.5 mg)

Drug

A dose of 0.25 mg semaglutide placebo gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.

Semaglutide 1.0 mg

Drug

A dose of 0.25 mg semaglutide gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.

Placebo (semaglutide 1.0 mg)

Drug

A dose of 0.25 mg semaglutide placebo gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.

Primary outcomes

  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

    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

    Calculated based on semaglutide measured in blood.

Secondary outcomes

  1. Maximum observed semaglutide plasma concentration at steady state

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

    Calculated based on semaglutide measured in blood.

  2. Time to maximum observed semaglutide plasma concentration at steady state

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

    Calculated based on semaglutide measured in blood.

  3. Total apparent clearance of semaglutide at steady state

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

    Calculated based on semaglutide measured in blood.

  4. Terminal elimination half-life of semaglutide at steady state

    Time frame: 0-840 hours after last administration of semaglutide

    Calculated based on semaglutide measured in blood.

  5. Apparent volume of distribution of semaglutide at steady state

    Time frame: 0-840 hours after last administration of semaglutide

    Calculated based on semaglutide measured in blood.

  6. Trough plasma semaglutide concentration

    Time frame: Before dosing at day 29, 57, 78, 85 and 92

    Calculated based on semaglutide measured in blood.

  7. Dose-corrected accumulation ratio

    Time frame: Based on the area under the semaglutide plasma concentration curve from 0-168 hours after the first dose and the area under the semaglutide plasma concentration curve 0-168 hours after the last dose

    Calculated based on semaglutide measured in blood.

  8. Area under the semaglutide plasma concentration time curve

    Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)

    Calculated based on semaglutide measured in blood.

  9. Maximum observed semaglutide plasma concentration

    Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)

    Calculated based on semaglutide measured in blood.

  10. Time to maximum observed semaglutide plasma concentration

    Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)

    Calculated based on semaglutide measured in blood.

  11. Number of treatment emergent adverse events (TEAEs)

    Time frame: Visit 2 (Day 1) - visit 23 (Day 120-127)

    Count and % of adverse events

  12. Number of hypoglycaemic episodes

    Time frame: Visit 2 (Day 1) - visit 23 (Day 120-127)

    Count of episodes

  13. Incidence of anti-semaglutide antibodies (positive/negative) at follow-up

    Time frame: Visit 23 (Day 120-127)

    Count of episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Single-centre, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 20, 2017
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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