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HyperlipidemiaPhase 1/2NCT03944109

The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia

A Phase 1/2 study testing SHR-1209 in people with Hyperlipidemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, placebo- controlled phaseⅠb/Ⅱclinical study. Totally 108 subjects are planned to enrolled with 36 subjects in three low-dose groups (group 1, group 2 and group 3) and 72 subjects in three high-dose groups (group 4, group 5, and group 6).12 subjects with hyperlipidemia who received… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hyperlipidemia
What is being tested?
SHR-1209
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteChina
Study dates
20 Jun 2019to 22 Dec 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and ≤65 years old;
  • Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can randomized to receive a stable dose of statin therapy for more than 28 days and are willing to maintain stable statin therapy in this study;
  • Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L of subjects who receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 3.4mmol/L of subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
  • Fasting triglycerides ≤4.5 mmol/L;
  • Body mass index (BMI) ≥18 and ≤ 35 kg/m2;
  • Signed informed consent.

Who cannot join

  • A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
  • Diagnosis of homozygous familial hypercholesterolemia;
  • New York heart association (NYHA) defined Ⅱ - Ⅳ history of heart failure;
  • History of acute coronary syndrome (e.g. myocardial infarction, hospitalization for unstable angina), or percutaneous coronary intervention, or coronary artery bypass graft, or history of cerebrovascular disease, within 12 months prior to screening;
  • Uncontrolled severe arrhythmias that are not controlled by drugs or other therapy within 12 months prior to enrollment;
  • Uncontrolled hypertension (systolic blood pressure ≥ 160 and/or diastolic blood pressure ≥ 100 mmHg);
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2.5x ULN;
  • Subjects with previous malignant tumor diseases. etc.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-Sen Memorial Hospital ,The Second Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia - A PhaseⅠb/Ⅱ Randomized, Double-Blind, Placebo-Controlled Clinical Study

This is a randomized, double-blind, placebo- controlled phaseⅠb/Ⅱclinical study. Totally 108 subjects are planned to enrolled with 36 subjects in three low-dose groups (group 1, group 2 and group 3) and 72 subjects in three high-dose groups (group 4, group 5, and group 6).12 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each low-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. 24 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each high-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. The primary objective of this study is to evaluate the safety, tolerability, and efficacy of multiple subcutaneous injections of SHR-1209 in hyperlipidemia subjects treated with stabilized dose of statin. Groups detail as follows:

  1. SHR-1209 dose 1 /placebo frequence 1
  2. SHR-1209 dose 2 /placebo frequence 2
  3. SHR-1209 dose 3 /placebo frequence 3
  4. SHR-1209 dose 4 /placebo frequence 1
  5. SHR-1209 dose 5 /placebo frequence 2
  6. SHR-1209 dose 6 /placebo frequence 3
Conditions
Hyperlipidemia
Being tested
SHR-1209, Placebo
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-1209Drug

    Pharmaceutical form: lyophilized formulation

    Route of administration: subcutaneous

  • PlaceboDrug

    Pharmaceutical form: lyophilized formulation

    Route of administration: subcutaneous

Study groups in NCT03944109
Study groupRoleWhat they receive
SHR-1209ExperimentalParticipants received one of 6 dose levels of SHR-1209 administered as multiple subcutaneous doses.
Receives: Drug: SHR-1209
PlaceboPlacebo comparatorParticipants received matching placebo dose regimens by subcutaneous injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary efficacy end point:Percent change from baseline to end of the dosing interval in LDL-C.

    Measured: Baseline to day 113 for group1,2,4,5 or day 169 for group 3,6

  2. Primary safety end point:Number of subjects with adverse events.

    Measured: Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5

Secondary outcomes (5)

  1. Absolute change from baseline to end of the dosing interval in LDL-C.

    Measured: Baseline to day 113 for group1,2,4,5 or day 169 for group 3,6

  2. Percent change from baseline to day 85 in LDL-C.

    Measured: Baseline to day 85 for all 6 groups

  3. Absolute change from baseline to day 85 in LDL-C.

    Measured: Baseline to day 85 for all 6 groups

  4. Percent change in PCSK9.

    Measured: Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5

  5. Absolute change in PCSK9.

    Measured: Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study start20 Jun 2019
  3. Primary completion22 Dec 2020
  4. Study completion22 Dec 2020

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03944109
Sponsor's protocol ID
SHR-1209-102
Status last verified
Jul 2022
First submitted
4 May 2019
Last updated
30 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.

    PubMed 40587053

  • Xu M, Zhu X, Wu J, Zhang Y, Zhao D, Wang X, Ding Y, Cao Y, Li C, Hu W, Sheng J, Luo Z, Zheng Z, Hu J, Liu J, Zhou X, Shen A, Ding X, Zhang Y, Zhao Y, Li Y, Zhong S, An S, Zou J, Yan L. PCSK9 inhibitor recaticimab for hypercholesterolemia on stable statin dose: a randomized, double-blind, placebo-controlled phase 1b/2 study. BMC Med. 2022 Jan 18;20(1):13. doi: 10.1186/s12916-021-02208-w.

    PubMed 35039035

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-1209 in people with Hyperlipidemia, run by Jiangsu HengRui Medicine 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 6 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: finished, as of the sponsor's last update on 30 Nov 2022. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary efficacy end point:Percent change from baseline to end of the dosing interval in LDL-C. (time frame: Baseline to day 113 for group1,2,4,5 or day 169 for group 3,6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03944109, which also lists 2 linked publications.

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 30 Nov 2022.

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