NCT04228354 is a Phase 1 clinical trial of Semaglutide in Healthy Volunteers, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT04228354?

NCT04228354 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT04228354?

Interventions in NCT04228354: Semaglutide.

What condition does NCT04228354 study?

NCT04228354 studies Healthy Volunteers, Overweight, Obesity.

Is NCT04228354 still recruiting?

NCT04228354 is currently completed. Last updated 10 January 2022.

Last reviewed 2022-01-10 · How we verify

NCT04228354

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

A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

Completed Phase 1 Last updated 10 January 2022

What this trial tests

Phase 1 trial testing Semaglutide in Healthy Volunteers in 28 participants. Completed in 1 June 2020.

Timeline

29 January 2020

Primary endpoint
1 June 2020

1 June 2020

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	28
Start date	29 January 2020
Primary completion	1 June 2020
Estimated completion	1 June 2020
Sites	1 location across Germany

Drugs / interventions tested

Semaglutide (semaglutide) — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →
Overweight — all drugs for Overweight →
Obesity — all drugs for Obesity →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

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

Sponsor's own description

The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions. Participants will get both versions of semaglutide. The order in which participants receive the versions is decided by chance. Participants will get the medicines as an injection under the skin of the belly with the use of a pen-injector. The study will last for about 11 to 17 weeks. Participants will have 27 visits with the study doctor. At 2 visits, participants will stay in the clinic for 4 days and 3 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Semaglutide

Trials testing the same drug.

NCT07430332 — GLP-1 RA for Stage 1 Type 1 Diabetes · Phase 2 · not yet recruiting
NCT06977438 — Promoting Healthy Children and Youth · Phase 4 · not yet recruiting
NCT07218354 — Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial · Phase 3 · not yet recruiting
NCT07511543 — Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy · Phase 2 · not yet recruiting
NCT07570810 — Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM · NA · not yet recruiting

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 NCT04228354 (US National Library of Medicine, public domain)
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: 10 January 2022

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/NCT04228354.

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