Adult Participants With Elevated Lipoprotein(a)Phase 2NCT07640217

A Phase II Clinical Study of SYH2068 Injection in Adults With Elevated Lipoprotein(a)

A Phase 2 study testing SYH2068 Dose 1, SYH2068 Dose 2 and SYH2068 Dose 3 in people with Adult Participants With Elevated Lipoprotein(a), run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Adult Participants With Elevated Lipoprotein(a)
What is being tested?: SYH2068 Dose 1, SYH2068 Dose 2 and SYH2068 Dose 3
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: No sites listed yet
Study dates: 30 Jul 2026to 30 Sep 2028
Phase: Phase 2

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female participants ≥18 years of age;
Elevated Lp(a);
Participants who have used lipid-lowering drugs continue to use a stable dose, and those who have not used do not start new lipid-lowering drugs;
Presence of ASCVD or ASCVD risk stratification assessed as moderate or high risk;
Participants are able to understand and cooperate to complete this study, voluntarily participate in this study, and sign the ICF.

Who cannot join

Diseases that significantly affect Lp(a) during screening period,
Major or unstable cardiovascular events occurring from 3 months before signing the ICF to randomization;
Undergoing or expected to undergo peripheral arterial, coronary, or cerebrovascular revascularization surgery or other major surgery within 3 months prior to signing the ICF until randomization or during the study period;
NYHA class III-IV at the time of signing the ICF or LVEF <40% during the screening period;
Type 1 diabetes or hereditary hemorrhagic disorder at screening;
History of malignant tumor or suspected malignancy within 5 years prior to screening;

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Use of drugs affecting Lp(a) within the specified period before screening or expected to use during the study period;
Allergy to oligonucleotide drugs;
Received any other clinical study treatment within 3 months prior to screening or within 5 half-lives of the investigational drug;
Female participants who are pregnant or breastfeeding at screening, or female / male participants who plan to conceive during the study and within 1 year after the last dose.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

0311-69085587

ctr-contact@cspc.cn

About this study

Official title: A Phase II Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial of SYH2068 Injection in Adults With Elevated Lipoprotein(a)

The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a).

Read the detailed description

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase II clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic characteristics of SYH2068 injection in adult participants with elevated lipoprotein(a). The study consists of a screening period and a treatment period.

Conditions: Adult Participants With Elevated Lipoprotein(a)
Being tested: SYH2068 Dose 1, SYH2068 Dose 2, SYH2068 Dose 3, Placebo

What participants receive

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

SYH2068 Dose 1Drug
Administered by subcutaneous injection.
SYH2068 Dose 2Drug
Administered by subcutaneous injection.
SYH2068 Dose 3Drug
Administered by subcutaneous injection.
PlaceboDrug
Administered by subcutaneous injection.

Study groups in NCT07640217
Study group	Role	What they receive
SYH2068 Dose 1	Experimental	Not described Receives: Drug: SYH2068 Dose 1
SYH2068 Dose 2	Experimental	Not described Receives: Drug: SYH2068 Dose 2
SYH2068 Dose 3	Experimental	Not described Receives: Drug: SYH2068 Dose 3
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Percentage change in Lp(a) from baseline to Day 60~180
Measured: Day 60~180

Secondary outcomes (7)

Percentage change in Lp(a) from baseline to Day 30~540
Measured: Day 30~540
The percentage of participants achieving Lp(a) < 125 nmol/L and <75 nmol/L.
Measured: Day 30~540
Changes of LDL-C from baseline to Day 30~540
Measured: Day 30~540
Changes of ApoB from baseline to Day 30~540
Measured: Day 30~540
Incidence of TEAEs during the treatment
Measured: During treatment
ADA incidence
Measured: During treatment
The plasma concentration of SYH2068.
Measured: During treatment

Timeline

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

30 Jul 202630 Sep 2028

First posted10 Jun 2026
Study start30 Jul 2026 (estimated)
Primary completion30 Mar 2028 (estimated)
Study completion30 Sep 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Adult Participants With Elevated Lipoprotein(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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07640217
Sponsor's protocol ID: SYH2068-002
Status last verified: Jun 2026
First submitted: 5 Jun 2026
Last updated: 10 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No