sHTGPhase 2NCT07889245
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
A Phase 2 study testing FXR0906 injection in people with sHTG and HTG With ASCVD (Diagnosed or at Increased Risk), run by Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)
- What is being tested?
- FXR0906 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2026to 24 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 3、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.
- 6、 Willing to follow dietary instructions and maintain a stable low-fat diet throughout the study period.
- 7、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.
- 8. Able to understand and comply with study procedures and willing to provide written informed consent form (ICF) prior to performing any study-specific procedures.
Who cannot join
- 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;
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- 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;
- Total bilirubin >2 × ULN, except in participants with Gilbert's syndrome;
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² (calculated using the MDRD formula);
- Random urine-protein-to-creatinine ratio >500 mg/g;
- Platelet count <100 × 10⁹/L;
- Clinically significant abnormalities in prothrombin time (PT), activated partial thromboplastin time (APTT), or international normalized ratio (INR) deemed by the Investigator to render the participant ineligible for the study;
- Other clinically significant abnormalities in laboratory safety parameters deemed by the Investigator to render the participant ineligible for the study;
- Untreated or inadequately treated hypothyroidism (i.e., thyroid-stimulating hormone [TSH] >2.0 × ULN or free thyroxine [FT4] ≤ lower limit of normal) or hyperthyroidism, as assessed by the Investigator. Participants with well-controlled thyroid disease (stable TSH on stable therapy for at least 4 weeks) are excluded from this criterion;
- Medical history of bleeding diathesis or coagulopathy;
- Current concomitant nephrotic syndrome;
- History of cirrhosis or Child-Pugh Class B or C at screening; or history of biliary obstruction;
- Positive human immunodeficiency virus (HIV) antibody at screening; hepatitis B virus (HBV) infection (positive hepatitis B surface antigen [HBsAg]); active hepatitis C virus (HCV) infection (participants with positive HCV antibody must undergo further HCV RNA testing to rule out active infection); or active syphilis infection;
- Active infection requiring systemic antiviral or antibacterial therapy within 2 weeks prior to randomization;
- History of malignancy within 5 years prior to screening, except for adequately treated basal-cell carcinoma, cutaneous squamous-cell carcinoma, superficial bladder tumor, or carcinoma in situ of the cervix;
- Receipt of any of the following therapies:
- Systemic corticosteroids or anabolic steroids within 4 weeks prior to randomization or planned use during the study (except for participants with documented history of hypogonadism [low testosterone] on stable-dose testosterone replacement therapy for ≥16 weeks prior to randomization);
- Plasma exchange within 4 weeks prior to randomization or planned plasma exchange during the study;
- Blood donation of more than 200 mL within 30 days prior to screening;
- Unwillingness to limit alcohol consumption during the study (maximum 14 units per week; 1 unit = 80 mL wine, 200 mL beer, or 25 mL of 40-proof spirits);
- Intolerance to subcutaneous injection, or skin conditions judged by the Investigator to render subcutaneous injection inappropriate (e.g., surgical wounds, burns). Acceptable injection sites are abdomen, thigh, or upper arm;
- Known hypersensitivity to the active ingredient or any excipient of the investigational product/placebo;
- Participation in another investigational medicinal product trial within 30 days prior to screening (or still within 5 half-lives of the study drug, whichever is longer), or a medical device clinical trial; or plan to participate in another clinical trial during this study; or residual effects deemed present by the Investigator;
- Medical conditions that, in the Investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion, or may reduce adherence or increase participant risk; participants who may be unable to complete this study for other reasons, or other conditions rendering the participant unsuitable for study participation as judged by the Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Haiyan Li, +86 010-82266226, haiyanli1027@hotmail.com
Yan Xu, +86 010-82265757, bysygcpoffice@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With Established or Increased Risk of Atherosclerotic Cardiovascular Disease.
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).
Read the detailed description
This phase II study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of FXR0906 injection in sHTG patients or HTG with ASCVD (diagnosed or at increased risk) patients. Eligible enrolled participants will be randomized to receive FXR0906 (dose 1, dose 2 or dose 3) or matched placebo and will be followed up for about 52 weeks.
- Being tested
- FXR0906 injection, Placebo
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FXR0906 injectionDrug
2 doses of FXR0906 (dose 1 ) by subcutaneous (sc) injection
FXR0906 injectionDrug
2 doses of FXR0906 (dose 2 ) by subcutaneous (sc) injection
FXR0906 injectionDrug
2 doses of FXR0906 (dose 3 ) by subcutaneous (sc) injection
PlaceboDrug
The placebo is normal saline (0.9%) and 2 doses of volume matched placebo will be administrated.
| Study group | Role | What they receive |
|---|---|---|
| FXR0906 dose 1 | Experimental | Dose 1 of FXR0906 injections administrated by subcutaneous injection Receives: Drug: FXR0906 injection |
| FXR0906 dose 2 | Experimental | Dose 2 of FXR0906 injections administrated by subcutaneous injection Receives: Drug: FXR0906 injection |
| FXR0906 dose 3 | Experimental | Dose 3 of FXR0906 injections administrated by subcutaneous injection Receives: Drug: FXR0906 injection |
| placebo | Placebo comparator | calculated volume to match different dose levels of active treatment by sc injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent change from baseline at week 24 in fasting triglycerides(TG)
Measured: baseline, week 24
Secondary outcomes (8)
percent change from baseline at week 48 in fasting triglycerides(TG)
Measured: baseline, week 48
percent change from baseline at week 24 and week 48 in Apolipoprotein (Apo)C-III
Measured: 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)
Measured: baseline, week 24 and week 48
percent change from baseline at week 24 and week 48 in fasting high-density lipoprotein cholesterol (HDL-C)
Measured: baseline, week 24 and week 48
percent change from baseline at week 24 and week 48 in fasting Apolipoprotein B (APOB)
Measured: baseline, week 24 and week 48
percent change from baseline at week 24 and week 48 in fasting low-density lipoprotein cholesterol (LDL-C)
Measured: baseline, week 24 and week 48
number of participants with Treatment-Emergent Adverse Events (TEAEs)T
Measured: From first dose of study drug up to Week 60
Changes in Plasma Concentration of FXR0906
To investigate changes in plasma concentrations of FXR0906 across different dose groups in participants with sHTG or HTG and ASCVD (confirmed or at increased risk)
Measured: Day1,Day3,Day169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start23 Oct 2026 (estimated)
- Primary completion24 Aug 2028 (estimated)
- Study completion24 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for sHTGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889245
- Sponsor's protocol ID
- FXR0906-HTG-201
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With Established or Increased Risk of Atherosclerotic Cardiovascular Disease.
- ClinicalTrials.gov ID
- NCT07889245
- Acronym / sponsor ID
- FXR0906-HTG-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 24 Aug 2028 (estimated)
- Study completion
- 24 Dec 2028 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This phase II study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of FXR0906 injection in sHTG patients or HTG with ASCVD (diagnosed or at increased risk) patients. Eligible enrolled participants will be randomized to receive FXR0906 (dose 1, dose 2 or dose 3) or matched placebo and will be followed up for about 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FXR0906 dose 1 | Experimental | Drug: FXR0906 injectionDose 1 of FXR0906 injections administrated by subcutaneous injection |
| FXR0906 dose 2 | Experimental | Drug: FXR0906 injectionDose 2 of FXR0906 injections administrated by subcutaneous injection |
| FXR0906 dose 3 | Experimental | Drug: FXR0906 injectionDose 3 of FXR0906 injections administrated by subcutaneous injection |
| placebo | Placebo comparator | Drug: Placebocalculated volume to match different dose levels of active treatment by sc injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
- 6、 Willing to follow dietary instructions and maintain a stable low-fat diet throughout the study period.
Key exclusion criteria (37 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FXR0906 injection2 doses of FXR0906 (dose 1 ) by subcutaneous (sc) injection | Drug | FXR0906 dose 1 |
| FXR0906 injection2 doses of FXR0906 (dose 2 ) by subcutaneous (sc) injection | Drug | FXR0906 dose 2 |
| FXR0906 injection2 doses of FXR0906 (dose 3 ) by subcutaneous (sc) injection | Drug | FXR0906 dose 3 |
| PlaceboThe placebo is normal saline (0.9%) and 2 doses of volume matched placebo will be administrated. | Drug | placebo |
Primary outcome
percent change from baseline at week 24 in fasting triglycerides(TG)
Time frame: baseline, week 24
8 secondary outcomes
percent change from baseline at week 48 in fasting triglycerides(TG)
Time frame: baseline, week 48
percent change from baseline at week 24 and week 48 in Apolipoprotein (Apo)C-III
Time frame: 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)
Time frame: baseline, week 24 and week 48
percent change from baseline at week 24 and week 48 in fasting high-density lipoprotein cholesterol (HDL-C)
Time frame: baseline, week 24 and week 48
percent change from baseline at week 24 and week 48 in fasting Apolipoprotein B (APOB)
Time frame: baseline, week 24 and week 48
percent change from baseline at week 24 and week 48 in fasting low-density lipoprotein cholesterol (LDL-C)
Time frame: baseline, week 24 and week 48
number of participants with Treatment-Emergent Adverse Events (TEAEs)T
Time frame: From first dose of study drug up to Week 60
Changes in Plasma Concentration of FXR0906
Time frame: Day1,Day3,Day169
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FXR0906 injection in people with sHTG and HTG With ASCVD (Diagnosed or at Increased Risk), run by Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yida Tang, PhD (+86 13901010211, tang_yida@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent change from baseline at week 24 in fasting triglycerides(TG) (time frame: baseline, week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.