ClinicalTrials.gg
Sign In
Not yet recruitingNCT07917143HCH UpliftMonoUpdated Nov 4, 2026

A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide Versus Placebo in Children and Adolescents With Hypochondroplasia

A Phase 3 interventional study of Navepegritide and Placebo for Navepegritide in Hypochondroplasia, sponsored by Ascendis Pharma A/S. Not yet recruiting. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Ascendis Pharma A/S · Phase 3, Interventional, and Treatment

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
01

Study summary

This trial is being conducted to evaluate the efficacy, safety and tolerability of treatment with navepegritide subcutaneous (SC) injections once weekly in children and adolescents with hypochondroplasia aged 2 to 17 years.

02

Conditions studied

  • Hypochondroplasia
03

In context

Lead sponsor

Ascendis Pharma A/S is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Age 2 to \<18 years at randomization
  • 2. Clinical diagnosis of HCH with documented genetic confirmation
  • 3. Height measurement available from medical records

Exclusion criteria

Exclusion Criteria:

  • 1. Evidence of growth plate closure
  • 2. Prior treatment with certain medication(s) which potentially could have affected growth
  • 3. History of any surgery intended to affect stature, growth, or body proportionality except procedures for leg bowing
  • 4. Unable to stand without assistance
  • 5. Known or suspected medical conditions other than hypochondroplasia that could affect growth
  • 6. Known history or presence of injury of the growth plates that affects growth potential of long bones
  • 7. Known history or presence of malignant disease
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
81 participants (estimated)

Study arms

  • Experimental
    Once weekly navepegritide sc.

    Drug: Navepegritide

  • Placebo comparator
    Once weekly placebo for navepegritide sc.

    Drug: Placebo for Navepegritide

Interventions

  • DrugNavepegritide

    Administered weekly as s.c. injection. Treatment duration of up to 104 weeks

  • DrugPlacebo for Navepegritide

    Administered weekly as s.c. injection. Treatment duration of up to 52 weeks of placebo for navepegritide followed by 52 weeks of navepegritide.

06

What researchers measure

Primary outcomes

  1. Annual Growth Velocity (AGV)

    To evaluate the AGV, cm per year, compared to placebo

    Time frame: Week 52

Secondary outcomes

  1. CDC-based height Z-score

    To evaluate the change from baseline in CDC-based height Z-score

    Time frame: Week 52

  2. Upper to lower body segment ratio

    Change from baseline in upper to lower body segment ratio

    Time frame: Week 52

  3. Quality of Life questionnaire

    Change from baseline in health related quality of life Quality of Life in Short Stature (QoLISSY)

    Time frame: Week 52

  4. Treatment-emergent Adverse Events (AE)

    Number of events

    Time frame: Throughout trial duration 104 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Oct 2028, 23 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2026
First posted
Nov 4, 2026
StartEst.
Nov 2026
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2029
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07917143
Lead sponsor
Ascendis Pharma A/S
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Nov 2026 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Oct 2029 (estimated)
Last update
Nov 4, 2026

Study contacts

Ascendis Registry Inquiries
Contact
asnd_registryinquiries@ascendispharma.com
+45 61242484
Medical Director, MD
study director · Ascendis Pharma A/S

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Navepegritide

Other studies in this condition

Hypochondroplasia

Other studies from this sponsor

Ascendis Pharma A/S

Start the discussion