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Not yet recruitingPhase 3

A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of DR10624 Added to Standard Icosapent Ethyl Therapy in Adults With Severe Hypertriglyceridemia

Asset

DR10624

Subcutaneous · GLP-1 / glucagon / FGF21 triple

Listed sites

2

Recruiting sites

-

Estimated enrollment

378

Study population

-

Eligibility highlights

•BMI 19-45

Primary endpoint

•Average fasting serum triglyceride concentration

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07680829
Org study IDDR10624-302

Timeline

Milestones

Study first posted2026-07-02actual
Last update posted2026-07-06actual
Study start2026-08estimated (month precision)
Primary completion2030-06estimated (month precision)
Study completion2030-10estimated (month precision)

Assets

Investigational agents

DR10624

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age ≥18 years, male or female; BMI 19.0-45.0 kg/m², body weight ≥50 kg at screening.

2. Fasting triglyceride (TG) range 5.65-22.60 mmol/L: single screening lab result meets range, plus average of two separate fasting TG tests (interval >1 week) within same range prior to randomization.

3. Stable lipid-lowering medications per local guidelines if on statin, cholesterol absorption inhibitor or PCSK9 inhibitor (minimum stable dose duration as required by drug class).

4. Females of childbearing potential agree effective contraception from ICF signing to 2 months post last dose; male participants agree contraception and no sperm donation for 3 months post last dose.

5. Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.

Exclusion criteria

1. Confirmed hereditary lipid disorders (Fredrickson Type 1/3, Apo C-II deficiency).

2. Significant weight loss or planned weight reduction during study.

3. Severe chronic liver, renal or advanced cardiac disease.

4. Uncontrolled diabetes or hypertension with severe complications.

5. Pancreatitis history or symptomatic gallbladder disease.

6. Recent major cardiovascular, bone or thyroid disorders.

7. Severe psychiatric illness or substance abuse history.

8. Prior GLP-1/GCGR/FGF21 agonists or other investigational drugs within 3 months.

9. Abnormal screening lab parameters related to liver, pancreas, kidney or viral infection.

10. Pregnant, breastfeeding or hypersensitivity to study treatments.

11. Investigator's judgment of unsuitability for participation.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
2
Other (unclassified)
2
MASH / liver
1
Cardiometabolic biomarkers
1
Other clinical outcomes
1

MASH / liver

1 endpoint
Secondary/protocol endpoint

Percent change from baseline LFC measured by MRI-PDFF Week26

Time frame:Baseline and Week 26

percent change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Primary/protocol endpoint

Percentage change from baseline in average fasting serum triglyceride concentration at Week 26

Time frame:Baseline up to Week 26 of double-blind treatment period

percent change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study

Time frame:First study drug injection through 4-week post-treatment safety follow-up

threshold achievement, event

Other/protocol endpoint

Percentage change from baseline in serum DR10624 concentration quantified by validated central laboratory bioanalytical assay

Time frame:First study drug injection through 4-week post-treatment safety follow-up

percent change from baseline, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Cumulative incidence of adjudicated acute pancreatitis up to Week 64

Time frame:Randomization through Week 64 double-blind treatment period

event count, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Percentage change from baseline in ApoC3 at Week 26

Time frame:Baseline to Week 26 of double-blind treatment

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage change from baseline in TRL-C at Week 26

Time frame:Baseline to Week 26 of double-blind treatment

percent change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.