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Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure

NCT03292653 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-05-11

Study results available
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Summary

Primary Objectives:

* Assess the safety and tolerability of sotagliflozin in hemodynamically stable participants with worsening of heart failure, compared to placebo.
* Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable participants with worsening of heart failure, compared to placebo.

Secondary Objectives:

* Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma erythropoietin levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.
* Explore the effect of sotagliflozin on changes in plasma N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.

Conditions

  • Cardiac Failure Aggravated

Interventions

DRUG

Sotagliflozin

Pharmaceutical form: Tablet; Route of administration: Oral

DRUG

Placebo

Pharmaceutical form: Tablet; Route of administration: Oral

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suman Wason, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2019-08-17
Completion
2019-08-17
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03292653 on ClinicalTrials.gov