A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.

NCT07889245 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: FXR0906-HTG-201
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial evaluating the efficacy and safety of FXR0906 in patients with severe hypertriglyceridemia or hypertriglyceridemia with atherosclerotic cardiovascular disease (diagnosed or at increased risk).

Conditions

sHTG; HTG With ASCVD (Diagnosed or at Increased Risk)

Outcome Measures

Primary Outcomes (1)

• percent change from baseline at week 24 in fasting triglycerides(TG)

  baseline, week 24

Secondary Outcomes (8)

• percent change from baseline at week 48 in fasting triglycerides(TG)

  baseline, week 48

• percent change from baseline at week 24 and week 48 in Apolipoprotein (Apo)C-III

  baseline, week 24 and week 48

• percent change from baseline at week 24 and week 48 in fasting non-high-density lipoprotein cholesterol (non-HDL-C)

  baseline, week 24 and week 48

• percent change from baseline at week 24 and week 48 in fasting high-density lipoprotein cholesterol (HDL-C)

  baseline, week 24 and week 48

• percent change from baseline at week 24 and week 48 in fasting Apolipoprotein B (APOB)

  baseline, week 24 and week 48

Study Arms (4)

FXR0906 dose 1

EXPERIMENTAL

Dose 1 of FXR0906 injections administrated by subcutaneous injection

Drug: FXR0906 injection

FXR0906 dose 2

EXPERIMENTAL

Dose 2 of FXR0906 injections administrated by subcutaneous injection

Drug: FXR0906 injection

FXR0906 dose 3

EXPERIMENTAL

Dose 3 of FXR0906 injections administrated by subcutaneous injection

Drug: FXR0906 injection

placebo

PLACEBO COMPARATOR

calculated volume to match different dose levels of active treatment by sc injection

Drug: Placebo

Interventions

FXR0906 injection DRUG

2 doses of FXR0906 (dose 1 ) by subcutaneous (sc) injection

FXR0906 dose 1

Placebo DRUG

The placebo is normal saline (0.9%) and 2 doses of volume matched placebo will be administrated.

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged between 18 and 75 years (inclusive) at screening;
• Body mass index (BMI) ranging from 18 to 40 kg/m² (inclusive) at screening; body weight \>45 kg for female participants and \>50 kg for male participants.
• 、Fall into at least 1 of the following groups (a or b):
• sHTG i) Medical history of fasting TG level ≥500 mg/dL (≥5.65 mmol/L); ii) Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L), obtained from two separate consecutive visits during the screening period with an interval of at least 7 days and no more than 14 days; iii) Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening; or
• HTG with ASCVD (diagnosed or at increased risk) i)Medical history of fasting TG ≥200 mg/dL (≥2.26 mmol/L) and \<500 mg/dL (\<5.65 mmol/L), with a confirmed diagnosis of ASCVD (per 2026 AHA/ACC guidelines: including acute coronary syndrome \[ACS\] (myocardial infarction \[MI\] and unstable angina), stable angina, coronary or other arterial revascularization, ischemic stroke, transient ischemic attack \[TIA\], or history of peripheral arterial disease \[PAD\]), or increased ASCVD risk (per 2026 AHA/ACC guidelines: participants with a risk ≥5% calculated using the PREVENT-ASCVD risk-calculator); ii) Mean fasting TG level ≥200 mg/dL (2.26 mmol/L) and \<500 mg/dL (5.65 mmol/L), obtained from two separate consecutive visits during the screening period with an interval of at least 7 days and no more than 14 days; iii) Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening. 4、 Prior to collection of qualifying TG levels, participants must receive standard-of-care lipid-lowering therapy in accordance with guidelines. For participants with ASCVD (diagnosed or at increased risk), therapy must include cholesterol-lowering agents (e.g., statins); 5. Participants receiving any of the following medications that may affect lipid levels must have the required stable treatment duration prior to screening and maintain stable dosing throughout the study period.
• 、 Willing to follow dietary instructions and maintain a stable low-fat diet throughout the study period.
• 、Participants of reproductive potential must agree to use highly effective contraceptive methods from screening until at least 9 months after the last dose of IP. Male participants must not donate sperm from screening until at least 9 months after the last dose of IP. Female participants of reproductive potential using hormonal contraception must have stable hormonal contraceptive use for more than one menstrual cycle prior to randomization.
• \. Able to understand and comply with study procedures and willing to provide written informed consent form (ICF) prior to performing any study-specific procedures.

You may not qualify if:

• Current use or use within 365 days prior to screening of any hepatocyte-targeted siRNA or antisense oligonucleotide molecules (including inclisiran);
• Known confirmed diagnosis of Familial Chylomicronemia Syndrome (FCS). For participants with suspected FCS without prior diagnosis, genetic testing results must be obtained prior to randomization to rule out FCS;
• Uncontrolled hypertension at screening (systolic blood pressure ≥160 mmHg \*\*and/or\*\* diastolic blood pressure ≥100 mmHg);
• Occurrence of acute pancreatitis within 12 weeks prior to screening;
• Heart failure classified as New York Heart Association (NYHA) Class III or IV at screening;
• Occurrence of acute coronary syndrome or cerebrovascular events (e.g., myocardial infarction, ischemic stroke) within 24 weeks prior to screening;
• Participants who have undergone coronary artery bypass grafting, percutaneous coronary intervention, peripheral vascular revascularization, heart valve replacement or other major surgery within 24 weeks prior to screening, or who plan to undergo major surgery during the study;
• Planned bariatric surgery or similar weight-reduction surgery from the time of signing the informed consent form through the end of the study;
• At screening, diabetic participants with any of the following:
• Type 1 diabetes mellitus;
• Newly-diagnosed type 2 diabetes mellitus within 12 weeks;
• Glycated hemoglobin (HbA1c) ≥8.5%;
• Hospitalization events related to diabetic ketoacidosis, hyperosmolar hyperglycemic state, other diabetic complications, recurrent infection, or poor glycemic control within 24 weeks prior to screening;
• At screening, any of the following laboratory values:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 × ULN;

Sponsors & Collaborators

• Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yida Tang, PhD

CONTACT

+86 13901010211; tang_yida@163.com

Yu Fu

CONTACT

+86 13671185050; lilac_fu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 22, 2026
• Study Start: October 23, 2026
• Primary Completion (Estimated): August 24, 2028
• Study Completion (Estimated): December 24, 2028
• Last Updated: October 22, 2026

Record last verified: 2026-10

Locations

CN (1)