NCT01514500 is a Phase 1 clinical trial of somapacitan in Growth Hormone Disorder, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT01514500?

NCT01514500 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT01514500?

Interventions in NCT01514500: somapacitan, placebo (somapacitan).

What condition does NCT01514500 study?

NCT01514500 studies Growth Hormone Disorder, Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children, Healthy.

Is NCT01514500 still recruiting?

NCT01514500 is currently completed. Last updated 24 December 2020.

Last reviewed 2020-12-24 · How we verify

NCT01514500

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

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

Completed Phase 1 Last updated 24 December 2020

What this trial tests

Phase 1 trial testing somapacitan in Growth Hormone Disorder in 105 participants. Completed in 18 March 2013.

Timeline

16 January 2012

Primary endpoint
18 March 2013

18 March 2013

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	105
Start date	16 January 2012
Primary completion	18 March 2013
Estimated completion	18 March 2013
Sites	1 location across Germany

Drugs / interventions tested

somapacitan (SOMAPACITAN) — full drug profile →
placebo (somapacitan) — full drug profile →

Conditions studied

Growth Hormone Disorder — all drugs for Growth Hormone Disorder →
Adult Growth Hormone Deficiency — all drugs for Adult Growth Hormone Deficiency →
Growth Hormone Deficiency in Children — all drugs for Growth Hormone Deficiency in Children →
Healthy — all drugs for Healthy →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 20 to 45, male only, with Growth Hormone Disorder or Adult Growth Hormone Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan.
Juul Kildemoes R, Højby Rasmussen M, Agersø H, Overgaard RV. · · 2021 · cited 27× · PMID 33313798 · DOI 10.1210/clinem/dgaa775
Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials.
Juul RV, Rasmussen MH, Agersø H, Overgaard RV. · · 2019 · cited 23× · PMID 29671202 · DOI 10.1007/s40262-018-0662-5
Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation.
Bidlingmaier M, Biller BMK, Clemmons D, Jørgensen JOL, et al · · 2022 · cited 9× · PMID 36619571 · DOI 10.3389/fendo.2022.1040046

Verify or expand the search:

Other trials of somapacitan

Trials testing the same drug.

NCT04970654 — A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared · Phase 3 · completed
NCT03905850 — A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy S · Phase 1 · completed
NCT03075644 — A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 5 · Phase 3 · completed
NCT02616562 — Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Nord · Phase 2 · completed
NCT02382939 — A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Prev · Phase 3 · completed

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 NCT01514500 (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: 24 December 2020

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/NCT01514500.

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