A research study investigating how semaglutide and dapagliflozin act in your body when dosed in one tablet

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

14 Jun 2022 → 13 Apr 2023

Decision date (initial)

2022-06-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2022-500007-52-00

WHO UTN

U1111-1266-4254

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Bioequivalence, Pharmacokinetic

To confirm that oral semaglutide and dapagliflozin steady state pharmacokinetics are not influenced by each other when dosed in a fixed- dose combination compared to when dosed alone in healthy participants.

Conditions and MedDRA coding

Diabetes Mellitus, Type 2

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Pharmaceuticals And Medical Devices Agency, European Medicines Agency, Health Canada

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or female
2. Aged 18-64 years (both inclusive) at the time of signing informed consent
3. Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive)
4. 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 7

1. Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lives of the investigational medicinal product, whichever is longer) before randomisation
2. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly-effective contraceptive method
3. Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
4. Use of tobacco and nicotine products, defined as any of the below: a) Smoking more than 5 cigarettes or the equivalent per day b) Not willing to refrain from smoking and use of nicotine substitute products during the in-house periods
5. Blood donation, plasma donation or blood draw, defined as any of the below: a) In excess of 400 mL within the past 90 days prior to the day of screening b) In excess of 50 mL within the past 30 days prior to the day of screening
6. 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
7. Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

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

Secondary endpoints 4

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 6

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications