Trial · NCT02287779

Safety and Tolerability Study of SHP626 in Overweight and Obese Adults

NCT02287779, Phase 1, Completed, Mirum Pharmaceuticals, Inc.; results first posted 2016-12-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Tolerability Study of SHP626 in Overweight and Obese Adults. Trials, record NCT02287779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02287779

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Trial

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

Title: Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
NCT number: NCT02287779
Status: Completed
Phases: Phase 1
Enrollment: 84 participants, actual
Lead sponsor: Mirum Pharmaceuticals, Inc.
Conditions: Non-Alcoholic Steatohepatitis
Interventions: SHP626, Placebo
First posted: 2014-11-11
Last updated: 2019-03-26
Results first posted: 2016-12-07
Limitations and caveats: None of the participants in the safety analysis set were included in the pharmacokinetic set because no participant had sufficient and interpretable primary pharmacokinetic data.

Source ClinicalTrials.gov

Registered outcomes16

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology	From the start of the study drug administration up to 9 days after the last dose of study drug administration	TEAEs were defined as events that either had a start date on or after the first dose of investigational medicinal product (IMP) or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An adverse event (AE) that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Hematology parameters included evaluation of hemoglobin, hematocrit, red blood cells, platelets, white blood cell count; total and differential, neutrophils (absolute), eosinophils (absolute), monocytes (absolute), basophils (absolute) and lymphocytes (absolute).
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)	From the start of the study drug administration up to 9 days after the last dose of study drug administration	TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Fat soluble vitamin included vitamin A (serum retinol), vitamin D (serum 25-hydroxycholecalciferol) and vitamin E (serum alfa-tocopherol).
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel	From the start of the study drug administration up to 9 days after the last dose of study drug administration	TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Lipid panel parameters included evaluation of total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and low-density lipoprotein (LDL) cholesterol.
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel	From the start of the study drug administration up to 9 days after the last dose of study drug administration	TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Thyroid hormone panel parameters included evaluation of thyroid hormones (TSH \[thyroid stimulating hormone\]; T3 \[triiodothyronine\] and T4 \[thyroxine\]).
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation	From the start of the study drug administration up to 9 days after the last dose of study drug administration	TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Coagulation included international normalized ratio, activated partial thromboplastin time and prothrombin time.
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry	From the start of the study drug administration up to 9 days after the last dose of study drug administration	TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Standard chemistry parameters included evaluation of sodium, potassium, glucose, blood urea nitrogen, creatinine, calcium, chloride, thyrotropin, thyroxine, tri-iodothyronine, phosphorus, protein, bicarbonate or carbon dioxide, albumin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, alkaline phosphatase, total bilirubin, urate, beta-human chorionic gonadotropin and follicle-stimulating hormone levels. Participant with TEAE related to standard chemistry were reported with hepatic enzyme increase.
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters	From the start of the study drug administration up to 9 days after the last dose of study drug administration	TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Urinalysis parameters included evaluation of pH, glucose, protein, nitrites, leukocyte esterase, occult blood, ketones, bilirubin and specific gravity levels.
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs	From the start of the study drug administration up to 9 days after the last dose of study drug administration	TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Vital signs parameter included evaluation of orthostatic blood pressure, respiratory rate and body temperature.
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead)	From the start of the study drug administration up to 9 days after the last dose of study drug administration	TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Twelve lead electrocardiogram parameters \[(heart rate (HR), PR, RR, QRS and QT intervals and information on T-wave morphology (normal/abnormal) and U-wave morphology (absent/normal or abnormal)\] were assessed.
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs)	From the start of the study drug administration up to 9 days after the last dose of study drug administration	TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology	From the start of the study drug administration up to 9 days after the last dose of study drug administration	Safety analysis set included all participants for whom a randomization number was assigned and who had taken \>= 1 dose of IMP.	participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)	From the start of the study drug administration up to 9 days after the last dose of study drug administration	Safety analysis set.	participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel	From the start of the study drug administration up to 9 days after the last dose of study drug administration	Safety analysis set.	participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel	From the start of the study drug administration up to 9 days after the last dose of study drug administration	Safety analysis set.	participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation	From the start of the study drug administration up to 9 days after the last dose of study drug administration	Safety analysis set.	participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry	From the start of the study drug administration up to 9 days after the last dose of study drug administration	Safety analysis set	participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters	From the start of the study drug administration up to 9 days after the last dose of study drug administration	Safety analysis set.	participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs	From the start of the study drug administration up to 9 days after the last dose of study drug administration	Safety analysis set.	participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead)	From the start of the study drug administration up to 9 days after the last dose of study drug administration	Safety analysis set.	participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs)	From the start of the study drug administration up to 9 days after the last dose of study drug administration	Safety analysis set.	participants	NUMBER

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group1,168

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

Outcome	Group	Units
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology	Placebo	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology	Volixibat 5 mg BID	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology	Volixibat 10 mg QD	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology	Volixibat 20 mg QD	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology	Volixibat 2-5-10-20 mg QD	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology	Volixibat 30 mg QD	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology	Volixibat 40 mg QD	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology	Volixibat 80-40-20 mg QD	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)	Placebo	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)	Volixibat 5 mg BID	participants

1 to 10 of 1,168Source ClinicalTrials.gov

See all 1,168 results by group

Participant flow24

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	21
Overall Study	STARTED	Volixibat 5 mg BID	9
Overall Study	STARTED	Volixibat 10 mg QD	9
Overall Study	STARTED	Volixibat 20 mg QD	9
Overall Study	STARTED	Volixibat 2-5-10-20 mg QD	9
Overall Study	STARTED	Volixibat 30 mg QD	9
Overall Study	STARTED	Volixibat 40 mg QD	9
Overall Study	STARTED	Volixibat 80-40-20 mg QD	9
Overall Study	COMPLETED	Placebo	21
Overall Study	COMPLETED	Volixibat 5 mg BID	9

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events208

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	Events
other	Tachycardia	Cardiac disorders	Placebo	0	21	0
other	Tachycardia	Cardiac disorders	Volixibat 5 mg BID	1	9	1
other	Tachycardia	Cardiac disorders	Volixibat 10 mg QD	0	9	0
other	Tachycardia	Cardiac disorders	Volixibat 20 mg QD	0	9	0
other	Tachycardia	Cardiac disorders	Volixibat 2-5-10-20 mg QD	0	9	0
other	Tachycardia	Cardiac disorders	Volixibat 30 mg QD	0	9	0
other	Tachycardia	Cardiac disorders	Volixibat 40 mg QD	0	9	0
other	Tachycardia	Cardiac disorders	Volixibat 80-40-20 mg QD	0	9	0
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	0	21	0
other	Abdominal discomfort	Gastrointestinal disorders	Volixibat 5 mg BID	1	9	1

1 to 10 of 208Source ClinicalTrials.gov

See all 208 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Volixibat 5 mg BID
Total, all-cause mortality	Volixibat 10 mg QD
Total, all-cause mortality	Volixibat 20 mg QD
Total, all-cause mortality	Volixibat 2-5-10-20 mg QD
Total, all-cause mortality	Volixibat 30 mg QD
Total, all-cause mortality	Volixibat 40 mg QD
Total, all-cause mortality	Volixibat 80-40-20 mg QD
Total, other adverse events	Placebo	13	21
Total, other adverse events	Volixibat 5 mg BID	9	9

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29548345	DERIVED

Source PubMed

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.

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