CompletedNCT05429593Updated Aug 7, 2024

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

A Phase 1 interventional study of Semaglutide and Dapagliflozin in Healthy Volunteers, sponsored by Novo Nordisk A/S. Completed at 2 sites in Germany. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 152
Allocation: Randomized
Ages: 18 Years to 64 Years
Sex: All

Study summary

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.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 152 participants (actual)

Study arms

Experimental
Part 1 sequence A
Semaglutide followed by Semaglutide/dapagliflozin
Drug: Semaglutide
Experimental
Part 1 sequence B
Semaglutide/dapagliflozin followed by Semaglutide
Drug: Semaglutide/dapagliflozin
Experimental
Part 2 sequence A
Dapagliflozin followed by Semaglutide/dapagliflozin
Drug: Dapagliflozin
Experimental
Part 2 sequence B
Semaglutide/dapagliflozin followed by dapagliflozin
Drug: Semaglutide/dapagliflozin

Interventions

DrugSemaglutide
Tablet given orally
DrugDapagliflozin
Tablet given orally
DrugSemaglutide/dapagliflozin
Tablet given orally

What researchers measure

Primary outcomes

AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state
measured in h\*nmol/L
Time frame: From 0 to 24 hours on day 49 and 84 in Part 1
AUC0-24h,dapa,ss: area under the dapagliflozin plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state
measured inh\*ng/mL
Time frame: From 0 to 24 hours on day 49 and 98 in Part 2

Secondary outcomes

Cmax,sema,ss: maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state)
measured in nmol/L
Time frame: From 0 to 24 hours on day 49 and 84 in Part 1
Cmax,dapa,ss: maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state
measured in ng/mL
Time frame: From 0 to 24 hours on day 49 and 98 in Part 2
tmax,sema,ss: time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state
measured in hours
Time frame: From 0 to 24 hours on day 49 and 84 in Part 1
tmax,dapa,ss: time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state
measured in hours
Time frame: From 0 to 24 hours on day 49 and 98 in Part 2

Study locations

2 sites

Novo Nordisk Investigational Site
Berlin, Brandenburg 14050, Germany
Parexel International GmbH
Berlin, 14050, Germany

References and documents

Individual participant data

Plan to share: Yes — "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05429593
Lead sponsor: Novo Nordisk A/S
Responsible party: Sponsor
First posted: Jun 23, 2022
Start date: Jun 22, 2022
Primary completion: Mar 10, 2023
Completion: Apr 13, 2023
Last update: Aug 7, 2024

Study contacts

Clinical Transparency (dept. 2834)

study director · Novo Nordisk A/S

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Novo Nordisk A/S

Start the discussion