## Protocol Section
### Identification Module
**NCT ID:** NCT05397379

**Brief Title:** A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis

**Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered HEC96719 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis

#### Organization Study ID Info
**ID:** HEC96719-NASH-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Sunshine Lake Pharma Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2023-09-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-09-05

**Type:** ACTUAL

#### Start Date
**Date:** 2021-11-15

**Type:** ACTUAL

**Status Verified Date:** 2022-05

#### Study First Post Date
**Date:** 2022-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-25
**Study First Submit QC Date:** 2022-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sunshine Lake Pharma Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HEC96719 in non-cirrhotic NASH patients.

### Conditions Module

**Conditions:**

- Non-Alcoholic Steatohepatitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 68

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Oral dose once daily for 12 weeks

**Intervention Names:**

- Drug: HEC96719

**Label:** HEC96719 0.25 mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Oral dose once daily for 12 weeks

**Intervention Names:**

- Drug: HEC96719

**Label:** HEC96719 0.35 mg

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Oral dose once daily for 12 weeks

**Intervention Names:**

- Drug: HEC96719

**Label:** HEC96719 0.5 mg

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Oral dose twice daily for 12 weeks

**Intervention Names:**

- Drug: HEC96719

**Label:** HEC96719 0.25 mg bid

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Oral dose once or twice daily for 12 weeks

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HEC96719 0.25 mg

- HEC96719 0.25 mg bid

- HEC96719 0.35 mg

- HEC96719 0.5 mg

**Description:** Oral tablets

**Name:** HEC96719

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Comparator

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Measure:** Mean Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 12

**Time Frame:** Baseline and Week 12

**Description:** Area under the curve

**Measure:** Plasma concentration of HEC96719 - AUC

**Time Frame:** 4 weeks

**Description:** Maximum observed concentration

**Measure:** Plasma concentration of HEC96719 - Cmax

**Time Frame:** 4 weeks

**Description:** Time to reach maximum measured plasma concentration

**Measure:** Plasma concentration of HEC96719 - Tmax

**Time Frame:** 4 weeks

**Description:** Determination of half-life

**Measure:** Plasma concentration of HEC96719 - t1/2

**Time Frame:** 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* An informed consent document must be signed and dated by the subject
* Male or female, 18 to 65 years of age
* Body mass index (BMI)≥18.0 and≤35.0 kg/m2, and Weight≥40 kg;
* Presumed NASH based on clinical characteristics or prior liver biopsy
* MRI PDFF liver fat content ≥ 10 %

Exclusion Criteria:

* previous diagnosis of other forms of chronic liver disease
* Laboratory Screening Results:

  * AST \> 5 x ULN
  * ALP \> 3 x ULN
  * Total bilirubin \> 1.5 x ULN
  * Albumin \< 3.2 g/dL
  * INR \> 1.3
  * Platelet count \< 100,000 /mm3
  * creatinine clearance \<60 ml/min (based on Cockroft Gault method)
* previous exposure to OCA
* uncontrolled diabetes mellitus
* presence of cirrhosis
* patients with contraindications to MRI imaging

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** Peking University People's Hospital

**State:** Beijing

**Location 2:**

**City:** Guangzhou

**Country:** China

**Facility:** NanFang Hospital of Southern Medical University

**State:** Guangdong

**Zip:** 510515

**Location 3:**

**City:** Guangzhou

**Country:** China

**Facility:** Affiliated Hospitol of Guangdong Medical University

**State:** Guangdong

**Location 4:**

**City:** Wuhan

**Country:** China

**Facility:** Union Hospital, TongJi Medical College, HuaZhong University of Science and Technology

**State:** Hubei

**Location 5:**

**City:** Changsha

**Country:** China

**Facility:** Hunan Provincial People's Hospital

**State:** Hunan

**Location 6:**

**City:** Changchun

**Country:** China

**Facility:** The First Hospital of Jilin University

**State:** Jilin

**Location 7:**

**City:** Xi'an

**Country:** China

**Facility:** The First Affiliated Hospitol of Xi'an Jiaotong University

**State:** Shanxi

**Location 8:**

**City:** Hangzhou

**Country:** China

**Facility:** The First Affiliated Hospital, Zhejiang University School of Medicine

**State:** Zhejiang

**Location 9:**

**City:** Wenzhou

**Country:** China

**Facility:** The First Affiliated Hospitol of Wenzhou Medical University

**State:** Zhejiang

#### Overall Officials

**Official 1:**

**Affiliation:** Nanfang Hospital, Southern Medical University

**Name:** Jinlin Hou, Doctor

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M8375

- Name: Fatty Liver

- Relevance: HIGH

- As Found: Steatohepatitis

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M30540

- Name: Non-alcoholic Fatty Liver Disease

- Relevance: HIGH

- As Found: Non-alcoholic Steatohepatitis

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5868

- Name: Visceral Steatosis

- Relevance: HIGH

- As Found: Steatohepatitis

### Condition Browse Module - Meshes

- ID: D000005234

- Term: Fatty Liver

- ID: D000065626

- Term: Non-alcoholic Fatty Liver Disease

### Misc Info Module

- Version Holder: 2024-05-24
