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NCT02616562 · ClinicalTrials.gov registry record · Phase 2

Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

A Phase 2 study, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 2
Development phase
76
Enrollment target

NCT02616562: Completed Phase 2 study, sponsored by Novo Nordisk A/S.

NCT02616562 is a Phase 2 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02616562, a Phase 2 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 2
Development phase
76 participants
Enrollment target

Study Summary

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency. The main trial period will consist of 26 weeks of treatment, followed by a 26 week extension period.

Primary Outcome

Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 26 as: HV = (height at 26 weeks visit- height at baseline) / (time from baseline to 26 weeks visit in years).

Interventions

  • DRUG somapacitan
  • DRUG Norditropin® FlexPro® pen

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2016-03-31
Est. Completion 2024-09-26
Phase Phase 2
Novo Nordisk A/S

431 total trials

What the finished NCT02616562 record still lists

NCT02616562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 2 interventions - of which somapacitan is the first listed.

NCT02616562 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02616562 about?

NCT02616562 is a clinical study titled "Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency". This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency. The main tria...

What is the current status of trial NCT02616562?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2016-03-31. Estimated completion is 2024-09-26.

What interventions are being tested in trial NCT02616562?

The interventions under investigation include: somapacitan (DRUG), Norditropin® FlexPro® pen (DRUG).

Who is sponsoring clinical trial NCT02616562?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02616562's enrollment target sits among peer trials

76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02616562, the US trial registry maintained by the National Library of Medicine. NCT02616562 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.