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Completed

NCT Number: NCT04187300

A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 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 they are pregnant, breast-feeding or planning to become pregnant during the study period.

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Key information

Conditions

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

Age range

18 year–65 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: No

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

Inclusion criteria

  • Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
  • Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)
  • Body weight between 70.0 and 130.0 kg (both inclusive)

Exclusion criteria

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
  • Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
  • Inability or unwillingness to perform self-injection

Treatment and study plan

semaglutide

Drug

Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks

Primary outcomes

  1. AUC0-168h,2.4mg,SS, Area under the semaglutide concentration time curve

    Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose

    h*nmol/L

  2. Cmax,2.4mg,SS, Maximum observed semaglutide concentration

    Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose

    nmol/L

Secondary outcomes

  1. AUC0-168h,1mg,SS, Area under the semaglutide concentration time curve

    Time frame: 0-168 hours (Day 78-85) after last 1 mg dose

    h*nmol/L

  2. Cmax,1mg,SS, Maximum observed semaglutide concentration

    Time frame: 0-168 hours (Day 78-85) after last 1 mg dose

    nmol/L

  3. Tmax,2.4mg,SS, Time of maximum observed semaglutide concentration after last 2.4 mg dose

    Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose

    h

  4. Tmax,1mg,SS, Time of maximum observed semaglutide concentration after last 1 mg dose

    Time frame: 0-168 hours (Day 78-85) after last 1 mg dose

    h

  5. t½, terminal elimination half-life of semaglutide after last 2.4 mg dose

    Time frame: 0-1176 hours (Day 141-190) after last 2.4 mg dose

    h

  6. Cl/F2.4mg, Total apparent clearance of semaglutide after last 2.4 mg dose

    Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose

    L/h

  7. Cl/F1mg, Total apparent clearance of semaglutide after last 1 mg dose

    Time frame: 0-168 hours (Day 78-85) after last 1 mg dose

    L/h

  8. Vss/F2.4mg, Apparent volume of distribution at steady-state of semaglutide after last 2.4 mg dose

    Time frame: 0-168 hours (Day 141-148) after last 2.4 mg dose

    L

  9. Vss/F1mg, Apparent volume of distribution at steady-state of semaglutide after last 1 mg dose

    Time frame: 0-168 hours (Day 78-85) after last 1 mg dose

    L

  10. Change in body weight

    Time frame: From baseline (Day 1, pre-dose) until the end of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial to Demonstrate Bioequivalence Between Semaglutide Formulation D With the DV3396 Pen-injector and Formulation B With the PDS290 Pen-injector in Subjects With Overweight or Obesity

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2019
Registry last updated
Nov 11, 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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