Completed

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

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What is being tested

Semaglutide

+ Dapagliflozin

+ Semaglutide/dapagliflozin

Drug
Who is being recruted

From 18 to 64 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2022
See protocol details

Summary

Principal SponsorNovo Nordisk A/S
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 22, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleA Study Comparing Exposure of Semaglutide and Dapagliflozin Dosed Orally as Mono-components Versus in a Fixed-dose Combination
NCT05429593
Principal SponsorNovo Nordisk A/S
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

152 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Semaglutide followed by Semaglutide/dapagliflozin

Group II

Experimental
Dapagliflozin followed by Semaglutide/dapagliflozin

Group III

Experimental
Semaglutide/dapagliflozin followed by Semaglutide

Group IV

Experimental
Semaglutide/dapagliflozin followed by dapagliflozin

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Novo Nordisk Investigational Site

Berlin, GermanyOpen Novo Nordisk Investigational Site in Google Maps
Suspended

Parexel International GmbH

Berlin, Germany
Completed2 Study Centers