Severe Hypertriglyceridemia (sHTG)Phase 3NCT07693777
A Phase III Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia
A Phase 3 study testing DR10624 Injection in people with Severe Hypertriglyceridemia (sHTG) and Hypertriglyceridemia, run by Zhejiang Doer Biologics Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of weekly subcutaneous DR10624 injection in adult patients with severe hypertriglyceridemia (sHTG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Hypertriglyceridemia (sHTG), Hypertriglyceridemia
- What is being tested?
- DR10624 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2026to 5 Dec 2029
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years at screening.
- BMI 19.0-45.0 kg/m², body weight ≥50.0 kg.
- Fasting triglyceride meets protocol-specified threshold at local lab and average of two separate central lab fasting samples collected ≥1 week apart.
- On stable guideline lipid-lowering therapy ≥4 weeks.
- Able to follow protocol and maintain stable lifestyle; sign voluntary written informed consent.
Who cannot join
- Confirmed/suspected familial severe hypertriglyceridemia subtypes (Fredrickson Type 1/3, ApoC-II deficiency).
- Unstable body weight, severe liver/kidney disease, uncontrolled diabetes or hypertension, NYHA III-IV heart failure, Cushing syndrome.
- History of acute pancreatitis within 6 months, chronic pancreatitis or symptomatic gallbladder disease.
- Recent major cardiovascular events, bone disorders, abnormal thyroid function or active malignancy within 5 years.
- Severe psychiatric disorders, substance abuse/excessive alcohol intake, or MTC/MEN2 family/personal history.
- Prior exposure to GLP-1R/GCGR/FGF21R agonists, relevant investigational drugs or other interventional trials within 3 months.
- Unqualified lab results at screening: abnormal liver/pancreas/renal indexes, elevated HbA1c, positive HIV/HBV/HCV, severe arrhythmia.
- Pregnancy/lactation, contraception refusal, hypersensitivity to study drug, blood donation ≥400mL recently, or any conditions judged by investigator to affect trial safety/efficacy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy and Safety of DR10624 in Subjects With Severe Hypertriglyceridemia Receiving Stable Lipid-Modifying Therapy
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of weekly subcutaneous DR10624 injection in adult patients with severe hypertriglyceridemia (sHTG). Eligible participants have persistently elevated fasting triglycerides despite stable background lipid-lowering therapy. Subjects will be randomized at a 2:2:1 ratio to three treatment arms: DR10624 low dose, DR10624 high dose, or matching placebo, receiving weekly subcutaneous injections for a total of 64 weeks double-blind treatment, followed by a 4-week post-treatment safety follow-up. The primary goal is to evaluate the percentage reduction in fasting triglycerides at Week 26. Secondary assessments include changes in ApoC3, remnant cholesterol, liver fat content measured by MRI-PDFF, incidence of adjudicated acute pancreatitis, and overall safety profile including treatment-emergent adverse events and immunogenicity.
- Being tested
- DR10624 Injection, Matching Placebo for DR10624
- Keywords
- Severe hypertriglyceridemia, hypertriglyceridemia, triglyceride, Apolipoprotein C3, remnant cholesterol, nonalcoholic fatty liver disease, MRI-PDFF, acute pancreatitis, DR10624, subcutaneous injection, lipid lowering therapy, phase 3 clinical trial, investigational new drug, hyperlipidemia
- Medical subject headings
- Hypertriglyceridemia, Non-alcoholic Fatty Liver Disease, Pancreatitis, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR10624 InjectionBiological
Novel investigational biologic agent for severe hypertriglyceridemia, administered via weekly subcutaneous injection with two titrated dose regimens (low-dose and high-dose) for 64 weeks double-blind treatment period.
Matching Placebo for DR10624Other
Volume-matched inert subcutaneous injection placebo, visually identical to DR10624 to maintain double-blind masking for all study participants.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 DR10624 Group | Experimental | Subcutaneous injection of DR10624 once weekly. Receives: Biological: DR10624 Injection |
| Dose 2 DR10624 Group | Experimental | Subcutaneous injection of DR10624 once weekly. Receives: Biological: DR10624 Injection |
| Placebo Group | Placebo comparator | Subcutaneous injection of placebo once weekly. Receives: Other: Matching Placebo for DR10624 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in central laboratory-measured fasting serum triglyceride at Week 26
Measured: Baseline to Week 26 of double-blind treatment
Secondary outcomes (8)
Percentage change from baseline in central laboratory-measured apolipoprotein C3 (ApoC3) at Week 26
Measured: Baseline to Week 26 double-blind treatment
Percentage change from baseline in central laboratory-measured triglyceride-rich lipoprotein cholesterol (TRL-C) at Week 26
Measured: Baseline to Week 26 double-blind treatment
Percentage change from baseline in central laboratory-measured non-high-density lipoprotein cholesterol (non-HDL-C) at Week 26
Measured: Baseline to Week 26 double-blind treatment
Proportion of participants achieving fasting triglyceride <5.65 mmol/L at Week 26
Measured: Week 26
Proportion of participants achieving fasting triglyceride <1.70 mmol/L at Week 26
Measured: Week 26
Percentage change from baseline in liver fat content quantified by blinded central MRI-PDFF imaging at Week 26
Measured: Baseline to Week 26 double-blind treatment
Cumulative proportion of participants with Event Adjudication Committee (EAC)-confirmed acute pancreatitis from randomization through Week 64
Measured: Randomization through Week 64 double-blind treatment
Overall incidence and maximum severity grade of all treatment-emergent adverse events (TEAEs)
Measured: First study drug injection through 4-week post-treatment safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start17 Aug 2026 (estimated)
- Primary completion14 Feb 2029 (estimated)
- Study completion5 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Hypertriglyceridemia (sHTG)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Doer Biologics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693777
- Sponsor's protocol ID
- DR10624-301
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy and Safety of DR10624 in Subjects With Severe Hypertriglyceridemia Receiving Stable Lipid-Modifying Therapy
- ClinicalTrials.gov ID
- NCT07693777
- Acronym / sponsor ID
- DR10624-301
- Keywords
- Severe hypertriglyceridemia, hypertriglyceridemia, triglyceride, Apolipoprotein C3, remnant cholesterol, nonalcoholic fatty liver disease, MRI-PDFF, acute pancreatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Zhejiang Doer Biologics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 14 Feb 2029 (estimated)
- Study completion
- 5 Dec 2029 (estimated)
- First posted
- 9 Jul 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 3 clinical trial to assess the efficacy and safety of weekly subcutaneous DR10624 injection in adult patients with severe hypertriglyceridemia (sHTG). Eligible participants have persistently elevated fasting triglycerides despite stable background lipid-lowering therapy. Subjects will be randomized at a 2:2:1 ratio to three treatment arms: DR10624 low dose, DR10624 high dose, or matching placebo, receiving weekly subcutaneous injections for a total of 64 weeks double-blind treatment, followed by a 4-week post-treatment safety follow-up. The primary goal is to evaluate the percentage reduction in fasting triglycerides at Week 26. Secondary assessments include changes in ApoC3, remnant cholesterol, liver fat content measured by MRI-PDFF, incidence of adjudicated acute pancreatitis, and overall safety profile including treatment-emergent adverse events and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 DR10624 Group | Experimental | Biological: DR10624 InjectionSubcutaneous injection of DR10624 once weekly. |
| Dose 2 DR10624 Group | Experimental | Biological: DR10624 InjectionSubcutaneous injection of DR10624 once weekly. |
| Placebo Group | Placebo comparator | Other: Matching Placebo for DR10624Subcutaneous injection of placebo once weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged ≥18 years at screening.
- BMI 19.0-45.0 kg/m², body weight ≥50.0 kg.
- Fasting triglyceride meets protocol-specified threshold at local lab and average of two separate central lab fasting samples collected ≥1 week apart.
- On stable guideline lipid-lowering therapy ≥4 weeks.
- Able to follow protocol and maintain stable lifestyle; sign voluntary written informed consent.
Key exclusion criteria (8 listed)
- Confirmed/suspected familial severe hypertriglyceridemia subtypes (Fredrickson Type 1/3, ApoC-II deficiency).
- Unstable body weight, severe liver/kidney disease, uncontrolled diabetes or hypertension, NYHA III-IV heart failure, Cushing syndrome.
- History of acute pancreatitis within 6 months, chronic pancreatitis or symptomatic gallbladder disease.
- Recent major cardiovascular events, bone disorders, abnormal thyroid function or active malignancy within 5 years.
- Severe psychiatric disorders, substance abuse/excessive alcohol intake, or MTC/MEN2 family/personal history.
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 |
|---|---|---|
| DR10624 InjectionNovel investigational biologic agent for severe hypertriglyceridemia, administered via weekly subcutaneous injection with two titrated dose regimens (low-dose and high-dose) for 64 weeks double-blind treatment period. | Biological | Dose 1 DR10624 Group, Dose 2 DR10624 Group |
| Matching Placebo for DR10624Volume-matched inert subcutaneous injection placebo, visually identical to DR10624 to maintain double-blind masking for all study participants. | Other | Placebo Group |
Primary outcome
Percentage change from baseline in central laboratory-measured fasting serum triglyceride at Week 26
Time frame: Baseline to Week 26 of double-blind treatment
8 secondary outcomes
Percentage change from baseline in central laboratory-measured apolipoprotein C3 (ApoC3) at Week 26
Time frame: Baseline to Week 26 double-blind treatment
Percentage change from baseline in central laboratory-measured triglyceride-rich lipoprotein cholesterol (TRL-C) at Week 26
Time frame: Baseline to Week 26 double-blind treatment
Percentage change from baseline in central laboratory-measured non-high-density lipoprotein cholesterol (non-HDL-C) at Week 26
Time frame: Baseline to Week 26 double-blind treatment
Proportion of participants achieving fasting triglyceride <5.65 mmol/L at Week 26
Time frame: Week 26
Proportion of participants achieving fasting triglyceride <1.70 mmol/L at Week 26
Time frame: Week 26
Percentage change from baseline in liver fat content quantified by blinded central MRI-PDFF imaging at Week 26
Time frame: Baseline to Week 26 double-blind treatment
Cumulative proportion of participants with Event Adjudication Committee (EAC)-confirmed acute pancreatitis from randomization through Week 64
Time frame: Randomization through Week 64 double-blind treatment
Overall incidence and maximum severity grade of all treatment-emergent adverse events (TEAEs)
Time frame: First study drug injection through 4-week post-treatment safety follow-up
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 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Severe Hypertriglyceridemia (sHTG)
Not yet recruitingPhase 2
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)
RecruitingPhase 1
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
Cardiovascular, Metabolic Disease
Not yet recruitingEarly Phase 1
CS-121 APOC3 Base Editing in Severe Hypertriglyceridemia
Severe Hypertriglyceridemia (sHTG)
Active, not recruitingPhase 3
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
Severe Hypertriglyceridemia
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.
Junbo Ge study chair
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DR10624 Injection in people with Severe Hypertriglyceridemia (sHTG) and Hypertriglyceridemia, run by Zhejiang Doer Biologics 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 5 inclusion and 8 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 10 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yongliang Fang (+86 057128256206, yf@dorebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in central laboratory-measured fasting serum triglyceride at Week 26 (time frame: Baseline to Week 26 of double-blind treatment). 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 10 Jul 2026.