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Weekly shot aims to tame dangerous fat levels in the blood

NCT ID NCT07693777

Disease control Sponsor: Zhejiang Doer Biologics Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This Phase 3 trial tests an investigational biologic called DR10624, given as a weekly injection, in adults with severe hypertriglyceridemia (very high blood fats) who are already on standard lipid-lowering therapy. The study compares two doses of DR10624 against a placebo to see if it can safely lower triglyceride levels and reduce related risks like pancreatitis. About 480 participants will receive weekly injections for 64 weeks, with the main goal of measuring the drop in fasting triglycerides at 26 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DR10624 (a biologic injection)
What this could lead to
If successful, this could provide a new weekly injection option to sharply lower severe high triglycerides and reduce the risk of pancreatitis.
What could go wrong
This is an early Phase 3 trial, so results may not confirm benefit or safety. Side effects from the injection or immune reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hyperlipidemia hypertriglyceridemia metabolic dysfunction-associated steatotic liver disease pancreatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertriglyceridemia Severe hypertriglyceridemia (SHTG)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zhongshan Hospital

    Shanghai, China

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