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OpenTrials
Completed

NCT Number: NCT04228354

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

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.

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Key information

Conditions

Healthy Volunteers Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Body mass index between 20.0 and 27.0 kg/m^2 (both inclusive).

Exclusion criteria

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods.
  • Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

Treatment and study plan

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

Primary outcomes

  1. Area under the semaglutide plasma concentration curve from 0 to tz

    Time frame: 0-840 hours

    h*nmol/L

  2. Maximum semaglutide plasma concentration

    Time frame: 0-840 hours

    nmol/L

Secondary outcomes

  1. Area under the semaglutide plasma concentration curve

    Time frame: 0-840 hours

    h*nmol/L

  2. Time to Cmax for semaglutide

    Time frame: 0-840 hours

    h

  3. Terminal elimination half-life

    Time frame: 0-840 hours

    h

  4. Total apparent clearance of semaglutide

    Time frame: 0-840 hours

    L/h

  5. Apparent volume of distribution of semaglutide

    Time frame: 0-840 hours

    L

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial to Demonstrate Bioequivalence Between Semaglutide Drug Product Concentrations 0.68 mg/mL and 1.0 mg/mL

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2020
Registry last updated
Jan 10, 2022

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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