Hyperlipoproteinemia (a)Phase 1/2NCT07172646
A Study of SRSD216 in Patients With Elevated Lipoprotein (a)
A Phase 1/2 study testing SRSD216 injection in people with Hyperlipoproteinemia (a), run by Sirius Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD216 and to identify a dose range for further studies in subjects with elevated Lp(a) level with or without ASCVD history. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipoproteinemia (a)
- What is being tested?
- SRSD216 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2025to Apr 2027
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions;
- Males or females, of any race;
- Body mass index (BMI) between 18.0 and 40.0 kg/m2, inclusive;
- Male subjects are not allowed to donate sperm, and female subjects are not allowed to donate eggs from the time the ICF is signed until at least 3 months after the last follow-up.
Who cannot join
- Any history or evidence of abnormal bleeding or coagulopathy; or evidence of prolonged or unexplained, clinically significant bleeding, or frequent unexplained bruising or thrombosis; or history of spontaneous bleeding;
- Evidence of active or suspected cancer within 3 years prior to screening (non-melanoma skin cancer, localized prostate cancer treated with curative intent, or other in situ carcinoma that does not require systemic therapy and is considered cured for at least 1 years is allowed);
- Acute febrile illness within 7 days prior to dose administration or evidence of active infection;
- Any major surgery within 3 months prior to screening or plan to have any major surgery during the study;
- History of clinically significant hypersensitivity, intolerance, or allergy to any oligonucleotide or GalNAc as determined by the investigator;
- Fasting TG≥ 500 mg/dL (5.6 mmol/L) during screening;
- Receipt of an investigational drug within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study;
- Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Site 01
Beijing, Beijing Municipality, 100000
Investigator, +86 21 61207756, medical@siriusrna.com
About this study
Official title: A Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose-Escalation and -Expansion Study to Evaluate the Safety, Tolerability, PK, and PD of Subcutaneously Administered SRSD216 in Patients With Elevated Lipoprotein(a)
This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD216 and to identify a dose range for further studies in subjects with elevated Lp(a) level with or without ASCVD history.
- Conditions
- Hyperlipoproteinemia (a)
- Being tested
- SRSD216 injection, Placebo
- Medical subject headings
- Hyperlipoproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRSD216 injectionDrug
Administered SC.
PlaceboDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| SRSD216 injection (Part 1) | Experimental | SRSD216 administered SC. in subjects of Part 1 Receives: Drug: SRSD216 injection |
| SRSD216 injection (Part 2) | Experimental | SRSD216 administered SC. in subjects of Part 2 Receives: Drug: SRSD216 injection; Drug: Placebo |
| 0.9% Sodium Chloride (Part 1) | Experimental | Placbo administered SC. in subjects of Part 1 Receives: Drug: Placebo |
| 0.9% Sodium Chloride (Part 2) | Placebo comparator | Placbo administered SC. in subjects of Part 2 Receives: Drug: SRSD216 injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
A summary of TEAE to evaluate the safety and tolerability of SRSD216
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start7 Apr 2025
- Primary completionMay 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperlipoproteinemia (a)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sirius Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Sirius Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172646
- Sponsor's protocol ID
- SRSD216-101
- Status last verified
- Jan 2026
- First submitted
- 21 Aug 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose-Escalation and -Expansion Study to Evaluate the Safety, Tolerability, PK, and PD of Subcutaneously Administered SRSD216 in Patients With Elevated Lipoprotein(a)
- ClinicalTrials.gov ID
- NCT07172646
- Acronym / sponsor ID
- SRSD216-101
- Conditions
- Hyperlipoproteinemia (a)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sirius Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Sep 2025 (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 two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD216 and to identify a dose range for further studies in subjects with elevated Lp(a) level with or without ASCVD history.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SRSD216 injection (Part 1) | Experimental | Drug: SRSD216 injectionSRSD216 administered SC. in subjects of Part 1 |
| SRSD216 injection (Part 2) | Experimental | Drug: SRSD216 injection, Drug: PlaceboSRSD216 administered SC. in subjects of Part 2 |
| 0.9% Sodium Chloride (Part 1) | Experimental | Drug: PlaceboPlacbo administered SC. in subjects of Part 1 |
| 0.9% Sodium Chloride (Part 2) | Placebo comparator | Drug: SRSD216 injection, Drug: PlaceboPlacbo administered SC. in subjects of Part 2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions;
- Males or females, of any race;
- Body mass index (BMI) between 18.0 and 40.0 kg/m2, inclusive;
- Male subjects are not allowed to donate sperm, and female subjects are not allowed to donate eggs from the time the ICF is signed until at least 3 months after the last follow-up.
Key exclusion criteria (8 listed)
- Any history or evidence of abnormal bleeding or coagulopathy; or evidence of prolonged or unexplained, clinically significant bleeding, or frequent unexplained bruising or thrombosis; or history of spontaneous bleeding;
- Evidence of active or suspected cancer within 3 years prior to screening (non-melanoma skin cancer, localized prostate cancer treated with curative intent, or other in situ carcinoma that does not require systemic therapy and is considered cured for at least 1 years is allowed);
- Acute febrile illness within 7 days prior to dose administration or evidence of active infection;
- Any major surgery within 3 months prior to screening or plan to have any major surgery during the study;
- History of clinically significant hypersensitivity, intolerance, or allergy to any oligonucleotide or GalNAc as determined by the investigator;
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 |
|---|---|---|
| SRSD216 injectionAdministered SC. | Drug | 0.9% Sodium Chloride (Part 2), SRSD216 injection (Part 1), SRSD216 injection (Part 2) |
| PlaceboAdministered SC. | Drug | 0.9% Sodium Chloride (Part 1), 0.9% Sodium Chloride (Part 2), SRSD216 injection (Part 2) |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 1 year
A summary of TEAE to evaluate the safety and tolerability of SRSD216
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 6 Jan 2026.
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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.
Medical Director, MD study director
Sirius Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SRSD216 injection in people with Hyperlipoproteinemia (a), run by Sirius Therapeutics 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 4 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: looking for participants now, as of the sponsor's last update on 6 Jan 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 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?
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 Medical Director (+86 21 61207756, medical@siriusrna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: 1 year). 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 6 Jan 2026.