A Multiple Ascending Dose Study of HTD1801 in Adults With... | NCT03381287

Label	Type	Description	Intervention Names
HTD1801 250 mg BID	Experimental	Subjects received 500 mg/day HTD1801	Drug: HTD1801 Tablets, 500 mg
HTD1801 500 mg BID	Experimental	Subjects received 1000 mg/day HTD1801	Drug: HTD1801 Tablets, 1000 mg
HTD1801 1000 mg BID	Experimental	Subjects received 2000 mg/day HTD1801	Drug: HTD1801 Tablets, 2000 mg
Placebo	Placebo Comparator		Drug: Placebo to match 500 mg HTD1801 Drug: Placebo to match 1000 mg HTD1801 Drug: Placebo to match 2000 mg HTD1801

Name	Type	Description	Arm Group Labels	Other Names
HTD1801 Tablets, 500 mg	Drug	500 mg/day (250 mg BID)	HTD1801 250 mg BID

Measure	Description	Time Frame
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)	TEAEs are defined as any AEs that commenced on or after exposure to study drug or any pre-existing AE that worsened in either intensity or frequency after exposure to study drug.	4 weeks

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax) of HTD1801 Components After Single-dose Oral Administration		0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1
Maximum Plasma Concentration (Cmax) of HTD1801 Components After Multiple-dose Oral Administration		0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28

Name	Affiliation	Role
Adrian Di Bisceglie, MD,FACP,FAASLD	HighTide Therapeutics USA, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Q-Pharm Pty Ltd.		Herston	Queensland	4006	Australia
CMAX Clinical Research Pty Ltd

PubMed Identifier	Type	Citation	Retractions
33183320	Derived	Di Bisceglie AM, Watts GF, Lavin P, Yu M, Bai R, Liu L. Pharmacokinetics and pharmacodynamics of HTD1801 (berberine ursodeoxycholate, BUDCA) in patients with hyperlipidemia. Lipids Health Dis. 2020 Nov 12;19(1):239. doi: 10.1186/s12944-020-01406-4.

ID	Title	Description
FG000	Placebo	Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID) Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID) Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
FG001	HTD1801 250 mg BID

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 19, 2018	Mar 13, 2022

ID	Title	Description
BG000	Placebo	Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID) Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID) Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
BG001	HTD1801 250 mg BID	Subjects received 500 mg/day HTD1801 HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
BG002	HTD1801 500 mg BID	Subjects received 1000 mg/day HTD1801 HTD1801 Tablets, 1000mg: 1000 mg/day (500 mg BID)
BG003	HTD1801 1000 mg BID	Subjects received 2000 mg/day HTD1801 HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00012 BG00112 BG00212 BG00314 BG00450

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)

TEAEs are defined as any AEs that commenced on or after exposure to study drug or any pre-existing AE that worsened in either intensity or frequency after exposure to study drug.

Posted

Count of Participants

Participants

4 weeks

ID	Title	Description
OG000	Placebo	Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID) Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID) Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
OG001	HTD1801 250 mg BID	Subjects received 500 mg/day HTD1801 HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
OG002	HTD1801 500 mg BID	Subjects received 1000 mg/day HTD1801 HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
OG003	HTD1801 1000 mg BID	Subjects received 2000 mg/day HTD1801 HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)

Units	Counts
Participants	OG00012 OG00112 OG00212 OG003

Title

Denominators

Categories

TEAE

Title	Measurements
	OG0008 OG00110 OG0028 OG003

Secondary

Maximum Plasma Concentration (Cmax) of HTD1801 Components After Single-dose Oral Administration

Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.

Posted

Mean

Standard Deviation

ng/mL

0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1

ID	Title	Description
OG000	HTD1801 250 mg	Subjects received a single 250 mg HTD1801 tablet administered orally
OG001	HTD1801 500 mg	Subjects received two 250 mg HTD1801 tablet administered orally
OG002	HTD1801 1000 mg	Subjects received four 250 mg HTD1801 tablet administered orally

Units	Counts
Participants	OG000

Secondary

Maximum Plasma Concentration (Cmax) of HTD1801 Components After Multiple-dose Oral Administration

Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.

Posted

Mean

Standard Deviation

ng/mL

0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28

ID	Title	Description
OG000	HTD1801 250 mg BID	Subjects received a single 250 mg HTD1801 tablet administered orally BID
OG001	HTD1801 500 mg BID	Subjects received two 250 mg HTD1801 tablet administered orally BID
OG002	HTD1801 1000 mg BID	Subjects received four 250 mg HTD1801 tablet administered orally BID

Units	Counts
Participants	OG000

Secondary

Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Single-dose Oral Administration

Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.

Posted

Median

Full Range

hours

0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1

ID	Title	Description
OG000	HTD1801 250 mg	Subjects received a single 250 mg HTD1801 tablet administered orally
OG001	HTD1801 500 mg	Subjects received two 250 mg HTD1801 tablet administered orally
OG002	HTD1801 1000 mg	Subjects received four 250 mg HTD1801 tablet administered orally

Units	Counts
Participants	OG000

Secondary

Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Multiple-dose Oral Administration

Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.

Posted

Median

Full Range

hours

0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28

ID	Title	Description
OG000	HTD1801 250 mg BID	Subjects received a single 250 mg HTD1801 tablet administered orally BID
OG001	HTD1801 500 mg BID	Subjects received two 250 mg HTD1801 tablet administered orally BID
OG002	HTD1801 1000 mg BID	Subjects received four 250 mg HTD1801 tablet administered orally BID

Units	Counts
Participants	OG000

Secondary

Plasma Half-life of HTD1801 Components (T1/2) After Single-dose Oral Administration

Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.

Posted

Mean

Standard Deviation

hours

0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1

ID	Title	Description
OG000	HTD1801 250 mg	Subjects received a single 250 mg HTD1801 tablet administered orally
OG001	HTD1801 500 mg	Subjects received two 250 mg HTD1801 tablet administered orally
OG002	HTD1801 1000 mg	Subjects received four 250 mg HTD1801 tablet administered orally

Units	Counts
Participants	OG000

Secondary

Plasma Half-life of HTD1801 Components (T1/2) After Multiple-dose Oral Administration

Specific PK samples were excluded from the PK analysis dataset as they were identified to have outside the established stability range for frozen sample storage.

Posted

Mean

Standard Deviation

hours

0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28

ID	Title	Description
OG000	HTD1801 250 mg BID	Subjects received a single 250 mg HTD1801 tablet administered orally BID
OG001	HTD1801 500 mg BID	Subjects received two 250 mg HTD1801 tablet administered orally BID
OG002	HTD1801 1000 mg BID	Subjects received four 250 mg HTD1801 tablet administered orally BID

Units	Counts
Participants	OG000

Secondary

Percent Change in Low-density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 28 Within and Between Treatment Groups

Posted

Mean

Standard Deviation

percentage change from baseline

Baseline, Day 14, Day 28

ID	Title	Description
OG000	Placebo	Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID) Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID) Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
OG001	HTD1801 250 mg BID	Subjects received 500 mg/day HTD1801 HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
OG002	HTD1801 500 mg BID	Subjects received 1000 mg/day HTD1801 HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
OG003	HTD1801 1000 mg BID	Subjects received 2000 mg/day HTD1801 HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)

Units

Secondary

Percent Change in Triglycerides From Baseline to Day 28 Within and Between Treatment Groups

Posted

Mean

Standard Deviation

percentage change from baseline

Baseline, Day 14, Day 28

ID	Title	Description
OG000	Placebo	Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID) Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID) Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
OG001	HTD1801 250 mg BID	Subjects received 500 mg/day HTD1801 HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
OG002	HTD1801 500 mg BID	Subjects received 1000 mg/day HTD1801 HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
OG003	HTD1801 1000 mg BID	Subjects received 2000 mg/day HTD1801 HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)

Units	Counts

Secondary

Percent Change in Free-fatty Acids (FFA) From Baseline to Day 28 Within and Between Treatment Groups

Posted

Mean

Standard Deviation

percentage change from baseline

Baseline, Day 14, Day 28

ID	Title	Description
OG000	Placebo	Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID) Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID) Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
OG001	HTD1801 250 mg BID	Subjects received 500 mg/day HTD1801 HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
OG002	HTD1801 500 mg BID	Subjects received 1000 mg/day HTD1801 HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
OG003	HTD1801 1000 mg BID	Subjects received 2000 mg/day HTD1801 HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)

Units	Counts

Secondary

Percent Change in Lipoprotein-A From Baseline to Day 28 Within and Between Treatment Groups

Posted

Mean

Standard Deviation

percentage change from baseline

Baseline, Day 14, Day 28

ID	Title	Description
OG000	Placebo	Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet BID) Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet BID) Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet BID)
OG001	HTD1801 250 mg BID	Subjects received 500 mg/day HTD1801 HTD1801 Tablets, 500 mg: 500 mg/day (250 mg BID)
OG002	HTD1801 500 mg BID	Subjects received 1000 mg/day HTD1801 HTD1801 Tablets, 1000 mg: 1000 mg/day (500 mg BID)
OG003	HTD1801 1000 mg BID	Subjects received 2000 mg/day HTD1801 HTD1801 Tablets, 2000 mg: 2000 mg/day (1000 mg BID)

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected12 at risk EG0015 affected12 at risk EG0024 affected12 at risk EG0033 affected14 at risk
Dizziness	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0012 affected12 at risk EG0020 affected12 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Lethargy	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Migraine	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Tremor	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0012 affected12 at risk EG0021 affected12 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Change of bowel habit	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Viral pharyngitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Rhinitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Catheter site erythema	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Catheter site pain	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Fatigue	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Malaise	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Ulcer	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0023 affected12 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Pruritis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Haematoma	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Phlebitis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Vascular pain	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo to match 500 mg HTD1801: 2 tablets/day (1 tablet bid) Placebo to match 1000 mg HTD1801: 4 tablets/day (2 tablet bid) Placebo to match 2000 mg HTD1801: 8 tablets/day (4 tablet bid)	12	0	12	8	12
EG001	HTD1801 250 mg BID	Subjects received 500 mg/day HTD1801 HTD1801 Tablets, 500mg: 500 mg/day (250 mg bid)	12	0	12	10	12
EG002	HTD1801 500 mg BID	Subjects received 1000 mg/day HTD1801 HTD1801 Tablets, 1000mg: 1000 mg/day (500 mg bid)	12	0	12	8	12
EG003	HTD1801 1000 mg BID	Subjects received 2000 mg/day HTD1801 HTD1801 Tablets, 2000mg: 2000 mg/day (1000 mg bid)	14	1	14	11	14