NCT04569994 is a Phase 1 clinical trial of NNC0363-0845 in Healthy Volunteers, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT04569994?

NCT04569994 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT04569994?

Interventions in NCT04569994: NNC0363-0845, Placebo (NNC0363-0845), Insulin degludec.

What condition does NCT04569994 study?

NCT04569994 studies Healthy Volunteers, Diabetes Mellitus, Type 1.

Is NCT04569994 still recruiting?

NCT04569994 is currently completed. Last updated 27 June 2023.

Last reviewed 2023-06-27 · How we verify

NCT04569994

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes

Completed Phase 1 Last updated 27 June 2023

What this trial tests

Phase 1 trial testing NNC0363-0845 in Healthy Volunteers in 68 participants. Completed in 23 June 2021.

Timeline

30 September 2020

Primary endpoint
23 June 2021

23 June 2021

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	68
Start date	30 September 2020
Primary completion	23 June 2021
Estimated completion	23 June 2021
Sites	1 location across Germany

Drugs / interventions tested

NNC0363-0845 — full drug profile →
Placebo (NNC0363-0845)
Insulin degludec (INSULIN DEGLUDEC) — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →
Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is investigating the safety and tolerability of the new investigational product NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the treatment of diabetes. The study consists of 3 parts. The first part of the study is conducted in healthy people, while the second part involves people with type 1 diabetes (T1D). Part 3 of this trial involves also people with T1D. The study will test how NNC0363-0845 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much the blood sugar is lowered. Healthy volunteers will either get NNC0363-0845 or placebo - which treatment is decided by chance. Participants with type 1 diabetes will either get NNC0363-0845 or insulin degludec (Tresiba®), also decided by chance. It is the first time that NNC0363-0845 is tested in humans. Participants will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left thigh. Participation in the study will last for up to 6 weeks. There will be one Informed Consent visit and 6 clinic visits with the study doctor. Healthy volunteers will have blood sampling to measure blood sugar and the concentration of the investigational product in the blood. Participants with type 1 diabetes will have a clamp experiment where the blood sugar is measured and controlled for up to 42 hours. For Part 3, the total duration of the trial for each individual is expected to be approximately 3-9 weeks. Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are of non-child bearing potential.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

In Silico Investigation of the Clinical Translatability of Competitive Clearance Glucose-Responsive Insulins.
Yang JF, Yang S, Gong X, Bakh NA, et al · · 2023 · cited 1× · PMID 37854621 · DOI 10.1021/acsptsci.3c00095

Verify or expand the search:

Other trials of NNC0363-0845

Trials testing the same drug.

NCT05134987 — A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants W · Phase 1 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04569994 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 27 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04569994.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing