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Completed

NCT Number: NCT05429593

A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet

This study will test how the active substances semaglutide and dapagliflozin act in the body (in terms of their levels in the blood), when they are taken in the form of a combination preparation (a tablet with a fixed dose combination) compared to when oral semaglutide and dapagliflozin are given alone.The study will consist of 2 parts. Part 1 will compare semaglutide to the fixed dose combination tablet (semaglutide/dapagliflozin) and part 2 will compare dapagliflozin to the fixed dose combination tablet (semaglutide/dapagliflozin). Participants will take part in either part 1 or part 2.

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Berlin, Brandenburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female
  • Aged 18-64 years (both inclusive) at the time of signing informed consent.
  • Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

  • Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lifes of the investigational medicinal product, whichever is longer) before randomisation.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly-effective contraceptive method.
  • Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Use of tobacco and nicotine products, defined as any of the below:
  • Smoking more than 5 cigarettes or the equivalent per day
  • Not willing to refrain from smoking and use of nicotine substitute products during the in-house periods
  • Blood donation, plasma donation or blood draw, defined as any of the below:
  • In excess of 400 mL within the past 90 days prior to the day of screening
  • In excess of 50 mL within the past 30 days prior to the day of screening
  • History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
  • Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

Treatment and study plan

semaglutide

Drug

Tablet given orally

Dapagliflozin

Drug

Tablet given orally

Semaglutide/dapagliflozin

Drug

Tablet given orally

Primary outcomes

  1. AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state

    Time frame: From 0 to 24 hours on day 49 and 84 in Part 1

    measured in h*nmol/L

  2. AUC0-24h,dapa,ss: area under the dapagliflozin plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state

    Time frame: From 0 to 24 hours on day 49 and 98 in Part 2

    measured inh*ng/mL

Secondary outcomes

  1. Cmax,sema,ss: maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state)

    Time frame: From 0 to 24 hours on day 49 and 84 in Part 1

    measured in nmol/L

  2. Cmax,dapa,ss: maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state

    Time frame: From 0 to 24 hours on day 49 and 98 in Part 2

    measured in ng/mL

  3. tmax,sema,ss: time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state

    Time frame: From 0 to 24 hours on day 49 and 84 in Part 1

    measured in hours

  4. tmax,dapa,ss: time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state

    Time frame: From 0 to 24 hours on day 49 and 98 in Part 2

    measured in hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Study Comparing Exposure of Semaglutide and Dapagliflozin Dosed Orally as Mono-components Versus in a Fixed-dose Combination

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2022
Registry last updated
Aug 7, 2024

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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