Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06481891 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy

A Phase 3 study of Non-obstructive Hypertrophic Cardiomyopathy and Obstructive Cardiomyopathy, Hypertrophic, sponsored by Lexicon Pharmaceuticals.

Recruiting
Registry status
Phase 3
Development phase
500
Enrollment target
20
Study locations

NCT06481891: Recruiting Phase 3 study of Non-obstructive Hypertrophic Cardiomyopathy and Obstructive Cardiomyopathy, Hypertrophic, sponsored by Lexicon Pharmaceuticals.

NCT06481891 is a Phase 3 study of Non-obstructive Hypertrophic Cardiomyopathy and Obstructive Cardiomyopathy, Hypertrophic that is actively recruiting participants, run by Lexicon Pharmaceuticals. The registered enrollment target is 500 participants, above the 97-participant average among 3 other Non-obstructive Hypertrophic Cardiomyopathy trials with a reported enrollment target (415% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06481891, a Phase 3 study of Non-obstructive Hypertrophic Cardiomyopathy and Obstructive Cardiomyopathy, Hypertrophic, is actively recruiting participants, sponsored by Lexicon Pharmaceuticals.

RECRUITING
Registry status
Phase 3
Development phase
500 participants
Enrollment target
20
Study locations

Study Summary

The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.

Primary Outcome

KCCQ is a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores are generated for e

Conditions Studied

Non-obstructive Hypertrophic Cardiomyopathy Obstructive Cardiomyopathy, Hypertrophic

Interventions

  • DRUG Placebo
  • DRUG Sotagliflozin

Study Locations (20)

California

  • Lexicon Investigational Site (4012) - Los Angeles
  • Lexicon Investigational Site (4035) - Pomona
  • Lexicon Investigational Site (4044) - San Francisco

Arizona

  • Lexicon Investigational Site (4041) - Phoenix
  • Lexicon Investigational Site (4037) - Scottsdale

Florida

  • Lexicon Investigational Site (4046) - Jacksonville
  • Lexicon Investigational Site (4034) - Orlando

Massachusetts

  • Lexicon Investigational Site (4016) - Boston
  • Lexicon Investigational Site (4042) - Boston

Michigan

  • Lexicon Investigational Site (4028) - Ann Arbor
  • Lexicon Investigational Site (4038) - Grand Rapids

New York

  • Lexicon Investigational Site (4039) - Manhasset
  • Lexicon Investigational Site (4043) - New York

Georgia

  • Lexicon Investigational Site (4018) - Atlanta

Illinois

  • Lexicon Investigational Site (4033) - Evanston

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2024-09-24
Est. Completion 2026-08
Phase Phase 3
Lexicon Pharmaceuticals

56 total trials

What NCT06481891 shows while recruiting

NCT06481891 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 97-participant average among 3 other Non-obstructive Hypertrophic Cardiomyopathy trials with a reported enrollment target (415% higher).

The record links to 2 conditions, with Non-obstructive Hypertrophic Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06481891 names 20 study sites across 13 states, led by California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT06481891 about?

NCT06481891 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy". The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.

What is the current status of trial NCT06481891?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2024-09-24. Estimated completion is 2026-08.

What conditions does trial NCT06481891 study?

This clinical trial studies the following conditions: Non-obstructive Hypertrophic Cardiomyopathy, Obstructive Cardiomyopathy, Hypertrophic.

What interventions are being tested in trial NCT06481891?

The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).

Who is sponsoring clinical trial NCT06481891?

This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06481891 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Non-obstructive Hypertrophic Cardiomyopathy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00001230 · 500 participants

    Host Response to Infection and Treatment in Filarial Diseases

  • NCT00001529 · 500 participants

    Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives

  • NCT00697411 · 500 participants

    Study of Selected X-Linked Disorders: Aicardi Syndrome

  • NCT00903110 · 500 participants

    Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT06481891

Source: ClinicalTrials.gov NCT06481891, the US trial registry maintained by the National Library of Medicine. NCT06481891 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.