Trial · NCT03292653

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

NCT03292653, Phase 2, Terminated, Lexicon Pharmaceuticals; results first posted 2021-05-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure. Trials, record NCT03292653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03292653

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure
NCT number: NCT03292653
Status: Terminated
Phases: Phase 2
Enrollment: 32 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Cardiac Failure Aggravated
Interventions: Sotagliflozin, Placebo
First posted: 2017-09-25
Last updated: 2021-05-11
Other registries' IDs: eudract:2017-002774-39
Results first posted: 2021-05-11

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Baseline up to Day 14	AE: is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participants at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. AESI: is an adverse event (serious or nonserious) of scientific and medical concern, specific to the IMP or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.
Primary	Change From Baseline in Hemoconcentration as Assessed by Changes in Albumin to Day 14	Baseline to Day 14
Primary	Change From Baseline in Hemoconcentration as Assessed by Changes in Hematocrit to Day 14	Baseline to Day 14
Primary	Change From Baseline in Hemoconcentration as Assessed by Changes in Hemoglobin to Day 14	Baseline to Day 14
Primary	Change From Baseline in Hemoconcentration as Assessed by Changes in Total Protein to Day 14	Baseline to Day 14
Primary	Changes From Baseline in Plasma Volume to Day 14	Baseline to 14 Days	Change in plasma volume in milliliters (mL) was assessed by the indicator dilution method using 131I-labelled human albumin.
Secondary	Change From Baseline in Erythropoietin to Day 14	Baseline to Day 14	Change in erythropoietin international units per liter (IU/L) was measured by chemiluminescent enzyme-labelled immunometric assay.
Secondary	Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) to Day 14	Baseline to Day 14	Change in NT-proBNP picomoles per liter (pmol/L) was measured by standard electrochemiluminescence immunoassay.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Baseline up to Day 14	Safety population included all randomized participants who had exposure to any amount of IMP.	percentage of participants	NUMBER
PRIMARY	Change From Baseline in Hemoconcentration as Assessed by Changes in Albumin to Day 14	Baseline to Day 14	Pharmacodynamic (PD) population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 End of Treatment (EOT). The number of participants analyzed is the number of participants with available data.	g/L	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in Hemoconcentration as Assessed by Changes in Hematocrit to Day 14	Baseline to Day 14	PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.	percentage of red blood cells	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in Hemoconcentration as Assessed by Changes in Hemoglobin to Day 14	Baseline to Day 14	PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.	g/L	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in Hemoconcentration as Assessed by Changes in Total Protein to Day 14	Baseline to Day 14	PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.	g/L	LEAST_SQUARES_MEAN
PRIMARY	Changes From Baseline in Plasma Volume to Day 14	Baseline to 14 Days	PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.	mL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Erythropoietin to Day 14	Baseline to Day 14	PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.	IU/L	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) to Day 14	Baseline to Day 14	PD population included all randomized and treated participants who had valid values of the main PD parameters at baseline and Day 14 (EOT). The number of participants analyzed is the number of participants with available data.	pmol/L	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Placebo	AEs	40	percentage of participants
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Sotagliflozin 200 mg	AEs	30	percentage of participants
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Sotagliflozin 400 mg	AEs	45.5	percentage of participants
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Placebo	SAEs	10	percentage of participants
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Sotagliflozin 200 mg	SAEs	0	percentage of participants
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Sotagliflozin 400 mg	SAEs	0	percentage of participants
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Placebo	AESIs	0	percentage of participants
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Sotagliflozin 200 mg	AESIs	0	percentage of participants
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Sotagliflozin 400 mg	AESIs	0	percentage of participants
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths	Placebo	AEs Leading to Discontinuation From the IMP	0	percentage of participants

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	11
Overall Study	STARTED	Sotagliflozin 200 mg	10
Overall Study	STARTED	Sotagliflozin 400 mg	11
Overall Study	COMPLETED	Placebo	10
Overall Study	COMPLETED	Sotagliflozin 200 mg	10
Overall Study	COMPLETED	Sotagliflozin 400 mg	10
Overall Study	NOT COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Sotagliflozin 200 mg	0
Overall Study	NOT COMPLETED	Sotagliflozin 400 mg	1

Source ClinicalTrials.gov

Adverse events60

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hypotension	Vascular disorders	Placebo	1	10
other	Hypotension	Vascular disorders	Sotagliflozin 200 mg	0	10
other	Hypotension	Vascular disorders	Sotagliflozin 400 mg	0	11
other	Gamma-glutamyltransferase increased	Investigations	Placebo	0	10
other	Gamma-glutamyltransferase increased	Investigations	Sotagliflozin 200 mg	0	10
other	Gamma-glutamyltransferase increased	Investigations	Sotagliflozin 400 mg	1	11
other	Cardiac failure	Cardiac disorders	Placebo	0	10
other	Cardiac failure	Cardiac disorders	Sotagliflozin 200 mg	0	10
other	Cardiac failure	Cardiac disorders	Sotagliflozin 400 mg	1	11
other	Myocardial infarction	Cardiac disorders	Placebo	0	10

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	10
Total, all-cause mortality	Sotagliflozin 200 mg	0	10
Total, all-cause mortality	Sotagliflozin 400 mg	0	11
Total, other adverse events	Placebo	4	10
Total, other adverse events	Sotagliflozin 200 mg	3	10
Total, other adverse events	Sotagliflozin 400 mg	5	11
Total, serious adverse events	Placebo	1	10
Total, serious adverse events	Sotagliflozin 200 mg	0	10
Total, serious adverse events	Sotagliflozin 400 mg	0	11

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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