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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 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.

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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.

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

Sponsor

Lexicon Pharmaceuticals

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06481891

The ClinicalTrials.gov registry entry for NCT06481891 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 97-participant average among 3 other Non-obstructive Hypertrophic Cardiomyopathy trials with a reported enrollment target (415% higher). The listed sponsor is Lexicon Pharmaceuticals, which has 56 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.