Not yet recruitingPhase 3

A Phase III Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia

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

Lead sponsor

Zhejiang Doer Biologics Co., Ltd.

Asset

DR10624

Subcutaneous · GLP-1 / glucagon / FGF21 triple

Listed sites

Recruiting sites

Estimated enrollment

480

Study population

Eligibility highlights

•BMI 19-45

Primary endpoint

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 IDNCT07693777

Org study IDDR10624-301

Timeline

Milestones

Study first posted2026-07-09actual

Last update posted2026-07-10actual

Study start2026-08-17estimated

Primary completion2029-02-14estimated

Study completion2029-12-05estimated

Assets

Investigational agents

DR10624

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Male or female aged ≥18 years at screening.

2. BMI 19.0-45.0 kg/m², body weight ≥50.0 kg.

3. Fasting triglyceride meets protocol-specified threshold at local lab and average of two separate central lab fasting samples collected ≥1 week apart.

4. On stable guideline lipid-lowering therapy ≥4 weeks.

5. Able to follow protocol and maintain stable lifestyle; sign voluntary written informed consent.

Exclusion criteria

1. Confirmed/suspected familial severe hypertriglyceridemia subtypes (Fredrickson Type 1/3, ApoC-II deficiency).

2. Unstable body weight, severe liver/kidney disease, uncontrolled diabetes or hypertension, NYHA III-IV heart failure, Cushing syndrome.

3. History of acute pancreatitis within 6 months, chronic pancreatitis or symptomatic gallbladder disease.

4. Recent major cardiovascular events, bone disorders, abnormal thyroid function or active malignancy within 5 years.

5. Severe psychiatric disorders, substance abuse/excessive alcohol intake, or MTC/MEN2 family/personal history.

6. Prior exposure to GLP-1R/GCGR/FGF21R agonists, relevant investigational drugs or other interventional trials within 3 months.

7. Unqualified lab results at screening: abnormal liver/pancreas/renal indexes, elevated HbA1c, positive HIV/HBV/HCV, severe arrhythmia.

8. Pregnancy/lactation, contraception refusal, hypersensitivity to study drug, blood donation ≥400mL recently, or any conditions judged by investigator to affect trial safety/efficacy.

Endpoints (0)

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.

No endpoints recorded for this trial.

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.