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TerminatedNCT04418297Updated Mar 2, 2023

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy

A Phase 1 interventional study of CT-G20 and Placebo in Cardiomyopathy, Hypertrophic Obstructive, sponsored by Celltrion. Terminated at 11 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-02.

Sponsored by Celltrion · Phase 1, Interventional, and Treatment

Why this study was terminated
The termination criteria of the protocol was met during dose escalation

From the registry’s dates

  • Primary completion was Nov 2022, 3 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

This is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment, ascending dose study in subjects with obstructive HCM aged 18-70 years. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20.

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Conditions studied

  • Cardiomyopathy, Hypertrophic Obstructive
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In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 23 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Celltrion is the lead sponsor of 76 studies on the registry; 3 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 13 (72%) have results posted.

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

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Men or women aged 18 to 70 years, inclusive at Screening
  2. Has established diagnosis of HCM defined by standard criteria as a maximal left ventricular wall thickness ≥15 mm at initial diagnosis in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed or ≥13 mm if the subject has a family history of HCM
  3. Has LVOT gradient ≥30 mmHg at rest or LVOT gradient ≥50 mmHg with Valsalva maneuver, due to SAM

Exclusion criteria

Exclusion Criteria:

  1. Known infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis or Noonan syndrome with LV hypertrophy
  2. History of persistent atrial fibrillation prior to Screening or Baseline
  3. History of paroxysmal atrial fibrillation requiring treatment (e.g., anti-coagulation and/or antiarrhythmic therapy) within 3 months prior to Screening
  4. Recently treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation) within 6 months prior to Screening or plans to have either of these treatments during the study
  5. Systolic heart failure with ejection fraction \<55% or heart failure symptoms of NYHA Class IV
  6. QTcF >480 msec at Screening or Baseline
  7. Presence of diseases classified as significant by the Investigator at Screening or Baseline, including the following but not limited to:

    1. Diabetes mellitus requiring treatment
    2. Moderate or severe renal insufficiency or renal insufficiency with estimated glomerular filtration rate \<70 mL/min/1.73m2
  8. Concomitant use of Disopyramide or Ranolazine within at least 7 days or 5 half-lives (whichever is longer) prior to Screening
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    CT-G20

    Drug: CT-G20

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugCT-G20

    oral tablet

  • DrugPlacebo

    oral tablet

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What researchers measure

Primary outcomes

  1. Incidence and severity of treatment-emergent adverse events and their relationship to the investigational product

    Time frame: 12 days

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Study locations

11 sites
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • New York University Langone Medical Center
    New York, New York 10016, United States
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 13620, Korea, Republic of
  • Chonnam National University Hospital
    Gwangju, 61469, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
  • Severance Hospital
    Seoul, 03722, Korea, Republic of
  • Samsung Medical Center
    Seoul, 06351, Korea, Republic of
  • Chung-Ang University Hospital
    Seoul, 06973, Korea, Republic of
  • Independent Public Central Clinical Hospital
    Warsaw, Mazowieckie 02097, Poland
  • Institute of Cardiology in Warsaw
    Warsaw, Mazowieckie 04628, Poland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04418297
Lead sponsor
Celltrion
Responsible party
Sponsor
First posted
Jun 5, 2020
Start date
Oct 23, 2020
Primary completion
Nov 22, 2022
Completion
Nov 22, 2022
Last update
Mar 2, 2023

Oversight

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

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This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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