Lp(a) lowering study of pelacarsen (TQJ230) with background inclisiran in participants with elevated Lp(a) and established ASCVD

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

17 Feb 2026 → ongoing

Decision date (initial)

2025-08-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

Evaluate the efficacy of pelacarsen compared to placebo, in reducing Lp(a) levels at Month 6 in ASCVD participants who have elevated Lp(a), and who are on background inclisiran for elevated LDL-C.

Secondary objectives 2

1. evaluate the efficacy of pelacarsen compared to placebo in reducing Lp(a) to <125 nmol/L at Month 6
2. Evaluate safety and tolerability of pelacarsen compared to placebo in participants on background inclisiran treatment

Conditions and MedDRA coding

Atherosclerotic cardiovascular disease (ASCVD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Male and female participants 18 to ≤80 years of age at Screening visit
2. Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
3. On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
4. Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
5. On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit
6. Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
7. Central laboratory reported LDL-C >70 mg/dL (or >1.8 mmol/L) at Screening visit

Exclusion criteria 12

1. Prior treatment with inclisiran
2. Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to Screening visit
3. Uncontrolled hypertension at Randomization/Baseline visit
4. Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
5. Triglycerides ≥400 mg/dL at Screening visit
6. History of malignancy of any organ system within the past 5 years
7. Myocardial infarction, stroke or other major bleeding, coronary or lower limb re-vascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)
8. Central laboratory reported platelet count <140,000 per mm3
9. Active liver disease or hepatic dysfunction at Screening visit
10. Significant kidney disease at Screening visit
11. Pregnant or nursing women at Screening visit
12. Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in log-transformed Lp(a) concentration from baseline at Month 6

Secondary endpoints 6

1. Proportion of participants achieving Lp(a) levels <125 nmol/L at Month 6
2. Incidence of treatment emergent adverse events (TEAEs):
3. Incidence of treatment emergent serious adverse events (TESAEs)
4. Incidence of treatment emergent adverse events of special interest (AESI)
5. Incidence of study and treatment discontinuations due to TEAEs;
6. Observed value and change/shift from baseline in safety laboratory measures; • ECGs • Vital signs • Laboratory values (e.g. CBC, CMP, Liver Function Tests)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 11

Locations

5 EU/EEA countries · 47 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 47 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications