Amoytop starts dosing Turner syndrome trial testing pegylated growth hormone
The Phase 3 trial pits Inpegsomatropin against Amoytop's own approved comparator Givopegsomatropin, adding to a pegylated growth hormone field crowded with weekly rivals.
Executive Summary
- A Phase 3 trial of Xiamen Amoytop Biotech's Inpegsomatropin in Turner syndrome moved to active recruiting status, with dosing now underway in China.
- The trial compares Inpegsomatropin against Amoytop's own already-marketed pegylated growth hormone, Givopegsomatropin, rather than placebo, setting a replication bar rather than a superiority one.
- Enrollment opened on schedule and at its full anticipated target, with no protocol amendments or timing slips since the trial first posted, a routine start for a registrational pediatric study.
- The trial sits in a pegylated growth hormone field that includes Ascendis Pharma's lonapegsomatropin and Novo Nordisk's somapacitan, both also running Phase 3 short-stature programs, meaning the mechanism class is established rather than novel.
- The primary completion date anchors a growth-velocity readout that will extend Amoytop's existing pegylated growth hormone evidence from general short stature into the Turner syndrome-specific population.
The status change
NCT07614152 moved from Not yet recruiting to Recruiting on July 22, 2026, with the trial's start date recorded as July 5, 2026. The study, sponsored by Xiamen Amoytop Biotech Co., Ltd., is a multicenter, randomized, open-label, positive-controlled Phase 3 trial evaluating Inpegsomatropin injection against Givopegsomatropin solution injection in prepubertal girls with Turner syndrome and short stature. It targets 84 patients across sites in China, with a primary completion date of March 30, 2028 and full trial completion set for February 28, 2030. NCT07614152The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short StatureNCT07614152
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
The primary endpoint is growth velocity in centimeters per year at week 52. Secondary endpoints track change in height standard deviation score, change in height velocity, change in IGF-1 standard deviation score, and the ratio of bone-age change to chronological-age change, all measured through week 52. Enrolled girls must be prepubertal, Tanner stage I, with bone age not advanced more than one year relative to chronological age and height below -2 standard deviations for age and gender, with no prior systemic growth-promoting treatment. Dosing is weekly and continues for 52 weeks in both arms, Inpegsomatropin at 280 mcg/kg/week against Givopegsomatropin at 200 mcg/kg/week. NCT07614152The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short StatureNCT07614152
Operational read
The registry shows a routine start. Enrollment opened at its full anticipated target of 84 with no increase or reduction, a change the operational model flags as typical since it falls well inside the +/-20% band the model uses to identify a real enrollment shift. No primary completion date changes, endpoint amendments, or eligibility changes have occurred since the trial first posted on May 29, 2026, and the only registry edits recorded are a title correction and the status update itself. That is a stable operational profile for a trial at this stage, not a signal in either direction. NCT07614152The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short StatureNCT07614152
Competitive and prior-evidence context
Inpegsomatropin already has a completed Phase 3 program in general short stature, also run by Xiamen Amoytop Biotech, positioning this Turner syndrome trial as an extension into a related but distinct pediatric population rather than a first test of the drug. The comparator arm uses Givopegsomatropin, itself a marketed pegylated growth hormone from the same sponsor, so the trial's bar is whether Inpegsomatropin's growth-velocity profile matches an already-established weekly agent rather than beating a placebo. The pegylated growth hormone class is mechanistically mature: Ascendis Pharma A/S is running a Phase 3 trial of lonapegsomatropin and Novo Nordisk A/S a Phase 3 trial of somapacitan, both in short stature, alongside earlier-phase pegylated entrants from Changchun GeneScience Pharmaceutical Co., Ltd. Against that field, the informative result is not whether a pegylated growth hormone can work in Turner syndrome, several already do, but whether Inpegsomatropin's weekly dosing regimen reproduces the growth-velocity response of its own comparator drug closely enough to support use in this specific population. NCT07614152The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short StatureNCT07614152
Sponsor track record
Xiamen Amoytop Biotech has completed 19 of 19 trials in its portfolio with none terminated, and currently runs five additional recruiting trials and three not-yet-recruiting studies across its 28-trial pipeline. That completion history supports operational confidence in the trial reaching its stated windows, though it says nothing about whether the growth-velocity result itself will replicate.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.