NCT02287779 is a Phase 1 clinical trial of SHP626 in Non-Alcoholic Steatohepatitis, sponsored by Mirum Pharmaceuticals, Inc..

Who is sponsoring NCT02287779?

NCT02287779 is sponsored by Mirum Pharmaceuticals, Inc..

What drugs are being tested in NCT02287779?

Interventions in NCT02287779: SHP626, Placebo.

What condition does NCT02287779 study?

NCT02287779 studies Non-Alcoholic Steatohepatitis.

Is NCT02287779 still recruiting?

NCT02287779 is currently completed. Last updated 26 March 2019.

Are results published for NCT02287779?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-03-26 · How we verify

NCT02287779

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Tolerability Study of SHP626 in Overweight and Obese Adults

Completed Phase 1 Results posted Last updated 26 March 2019

What this trial tests

Phase 1 trial testing SHP626 in Non-Alcoholic Steatohepatitis in 84 participants. Completed in 19 June 2015.

Timeline

19 January 2015

Primary endpoint
19 June 2015

19 June 2015

Quick facts

Lead sponsor	Mirum Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	84
Start date	19 January 2015
Primary completion	19 June 2015
Estimated completion	19 June 2015
Sites	1 location across United States

Drugs / interventions tested

SHP626 — full drug profile →
Placebo

Conditions studied

Non-Alcoholic Steatohepatitis — all drugs for Non-Alcoholic Steatohepatitis →

Sponsor

Mirum Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Non-Alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology Primary · 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 (a

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	0
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) Primary · 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).

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	0
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel Primary · 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.

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	0
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel Primary · 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 \[thyroxine\]).

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	0
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation Primary · 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.

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	0
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry Primary · 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 aminotrans

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	0
Volixibat 10 mg QD	0
Volixibat 20 mg QD	1
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters Primary · 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.

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	0
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs Primary · 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.

Tachycardia

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	1
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Pyrexia

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	2
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) Primary · 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.

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	0
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) Primary · From the start of the study drug administration up to 9 days after the last dose of study drug administration

Participants with TEAEs

Group	Value	95% CI
Placebo	14
Volixibat 5 mg BID	9
Volixibat 10 mg QD	9
Volixibat 20 mg QD	9
Volixibat 2-5-10-20 mg QD	9
Volixibat 30 mg QD	9
Volixibat 40 mg QD	9
Volixibat 80-40-20 mg QD	9

Participants with STEAEs

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	0
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study Primary · From the start of the study drug administration up to 9 days after the last dose of study drug administration

Group	Value	95% CI
Placebo	0
Volixibat 5 mg BID	0
Volixibat 10 mg QD	0
Volixibat 20 mg QD	0
Volixibat 2-5-10-20 mg QD	0
Volixibat 30 mg QD	0
Volixibat 40 mg QD	0
Volixibat 80-40-20 mg QD	0

Average Total Fecal Bile Acid (FBA) Concentration Secondary · Day -2 up to Day 14

Stool samples for the determination of total FBA were collected in 48-hour windows from 48 hours before dosing on Day 1 through Day 14. The average of daily total FBA excretion is calculated before (Day -1 and Day -2) as the first pre dose of IMP and after (Day 1-12) as the first post-dose of IMP. The FBA is calculated as Total FBA (micromoles) = FBA (micromol per liter) \* weight (grams) divided by 10\^3. Participants with fecal bile acid concentration and their average pre-first dose and average post-first dose were reported.

Average Pre First Dose

Group	Value	95% CI
Placebo	183.84	± 176.229
Volixibat 5 mg BID	166.95	± 84.057
Volixibat 10 mg QD	172.49	± 180.992
Volixibat 20 mg QD	238.22	± 211.406
Volixibat 2-5-10-20 mg QD	364.78	± 304.905
Volixibat 30 mg QD	408.49	± 475.553
Volixibat 40 mg QD	335.89	± 277.883
Volixibat 80-40-20 mg QD	116.73	± 91.962

Average Post First Dose

Group	Value	95% CI
Placebo	224.75	± 195.403
Volixibat 5 mg BID	941.32	± 338.783
Volixibat 10 mg QD	668.64	± 365.183
Volixibat 20 mg QD	1051.86	± 554.781
Volixibat 2-5-10-20 mg QD	1055.60	± 394.246
Volixibat 30 mg QD	987.01	± 321.184
Volixibat 40 mg QD	1172.08	± 591.774
Volixibat 80-40-20 mg QD	665.82	± 539.150

Adverse events — posted to ClinicalTrials.gov

Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/21 (0%)

Deaths: —

Volixibat 5 mg BID

Serious: 0/9 (0%)

Deaths: —

Volixibat 10 mg QD

Serious: 0/9 (0%)

Deaths: —

Volixibat 20 mg QD

Serious: 0/9 (0%)

Deaths: —

Volixibat 2-5-10-20 mg QD

Serious: 0/9 (0%)

Deaths: —

Volixibat 30 mg QD

Serious: 0/9 (0%)

Deaths: —

Volixibat 40 mg QD

Serious: 0/9 (0%)

Deaths: —

Volixibat 80-40-20 mg QD

Serious: 0/9 (0%)

Deaths: —

Other adverse events (26 terms — click to expand)

Reaction	System	Placebo	Volixibat 5 mg BID	Volixibat 10 mg QD	Volixibat 20 mg QD	Volixibat 2-5-10-20 mg QD	Volixibat 30 mg QD	Volixibat 40 mg QD	Volixibat 80-40-20 mg QD
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Anorectal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Defaecation urgency	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gastrointestinal sounds abnormal	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Haematochezia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Proctalgia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Application site irritation	General disorders	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—
Thermal burn	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Hepatic enzyme increased	Investigations	—	—	—	—	—	—	—	—
Muscle contracture	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Dizziness postural	Nervous system disorders	—	—	—	—	—	—	—	—
Erection increased	Reproductive system and breast disorders	—	—	—	—	—	—	—	—
Dry throat	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Dermatitis allergic	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT02287779 adverse events section.

Sponsor's own description

This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

SLC transporters as therapeutic targets: emerging opportunities.
Lin L, Yee SW, Kim RB, Giacomini KM. · · 2015 · cited 653× · PMID 26111766 · DOI 10.1038/nrd4626
Intestinal microbiome and NAFLD: molecular insights and therapeutic perspectives.
Hu H, Lin A, Kong M, Yao X, et al · · 2020 · cited 142× · PMID 31845054 · DOI 10.1007/s00535-019-01649-8
Current Options and Future Directions for NAFLD and NASH Treatment.
Zhang C, Yang M. · · 2021 · cited 66× · PMID 34299189 · DOI 10.3390/ijms22147571
A randomised, double-blind, placebo-controlled phase 1 study of the safety, tolerability and pharmacodynamics of volixibat in overweight and obese but otherwise healthy adults: implications for treatment of non-alcoholic steatohepatitis.
Palmer M, Jennings L, Silberg DG, Bliss C, et al · · 2018 · cited 25× · PMID 29548345 · DOI 10.1186/s40360-018-0200-y

Verify or expand the search:

Other trials of SHP626

Trials testing the same drug.

NCT02787304 — Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) · Phase 2 · terminated
NCT02571192 — A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose · Phase 1 · completed

Other recruiting trials for Non-Alcoholic Steatohepatitis

Currently open trials in the same condition.

NCT05065593 — The Effect of Aerobic and Resistant Exercise Training in Patients With Non-Alcoholic Steatohepatitis · NA · active not recruiting
NCT04690972 — "Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chron · recruiting
NCT03884075 — Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES) · Phase 2 · recruiting

Other Mirum Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT07454837 — Phase 2b/3 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide · Phase 2, PHASE3 · recruiting
NCT07290257 — Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome i · Phase 4 · recruiting
NCT07200908 — A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) · Phase 3 · recruiting
NCT06193928 — Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US) · recruiting
NCT04729751 — A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases In · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02287779 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mirum Pharmaceuticals, Inc.
Last refreshed: 26 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02287779.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02287779

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of SHP626

Other recruiting trials for Non-Alcoholic Steatohepatitis

Other Mirum Pharmaceuticals, Inc. trials

Verify against primary sources