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NCT00715689
Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)
Phase 2 trial testing NNC126-0083 in Growth Hormone Disorder in 33 participants. Completed in 1 March 2009.
1 March 2009
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 1 July 2008 |
| Primary completion | 1 March 2009 |
| Estimated completion | 1 March 2009 |
| Sites | 3 locations across Denmark |
Drugs / interventions tested
- NNC126-0083 — full drug profile →
- NNC126-0083 — full drug profile →
- NNC126-0083 — full drug profile →
- NNC126-0083 — full drug profile →
- placebo
- placebo
- placebo
- placebo
Conditions studied
- Growth Hormone Disorder — all drugs for Growth Hormone Disorder →
- Adult Growth Hormone Deficiency — all drugs for Adult Growth Hormone Deficiency →
Sponsor
Novo Nordisk A/S — full company profile →
Who can join
Adults 20 to 65, any sex, with Growth Hormone Disorder or Adult Growth Hormone Deficiency. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and tolerability (adverse events, local tolerability, physical examination)
Time frame: 0 to 10 days after third dosing, (day 15-25 after first dose)
Sponsor's own description
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults
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:
- PubMed search for NCT00715689
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Novo Nordisk A/S trials
Trials by the same sponsor.
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT00715689 (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: 6 February 2017
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/NCT00715689.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing