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

NCT05429593 | Completed Phase 1

• 3 other identifiers: NN9917-4751U1111-1266-42542022-500007-52-00
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

Brief 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

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

  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

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

Secondary Outcomes (4)

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

  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

  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

  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

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

Study Arms (4)

Part 1 sequence A

EXPERIMENTAL

Semaglutide followed by Semaglutide/dapagliflozin

Drug: Semaglutide

Part 1 sequence B

EXPERIMENTAL

Semaglutide/dapagliflozin followed by Semaglutide

Drug: Semaglutide/dapagliflozin

Part 2 sequence A

EXPERIMENTAL

Dapagliflozin followed by Semaglutide/dapagliflozin

Drug: Dapagliflozin

Part 2 sequence B

EXPERIMENTAL

Semaglutide/dapagliflozin followed by dapagliflozin

Drug: Semaglutide/dapagliflozin

Interventions

Semaglutide DRUG

Tablet given orally

Part 1 sequence A

Dapagliflozin DRUG

Tablet given orally

Part 2 sequence A

Semaglutide/dapagliflozin DRUG

Tablet given orally

Part 1 sequence B; Part 2 sequence B

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Novo Nordisk Investigational Site

Berlin, Brandenburg, 14050, Germany

Location

Parexel International GmbH

Berlin, 14050, Germany

Location

MeSH Terms

Interventions

semaglutide; dapagliflozin

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: June 22, 2022
• Primary Completion: March 10, 2023
• Study Completion: April 13, 2023
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)