NCT07460960 Pitavastatin Calcium Atherosclerosis Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07460960 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.

MCP evidence snapshot: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07460960 is a hot trial to watch

Atherosclerosis is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07460960 is notable because it evaluates Pitavastatin Calcium in a Phase 2 design sponsored by Moscow State University Lomonosov. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

Aim. To study the effect of different intensities of statin therapy on androgen status and erectile function in men aged 40-65 years with high and very high cardiovascular risk. Additionally, to assess the association between sex hormone levels, erectile function parameters, and traditional cardiovascular risk factors, arterial stiffness, and endothelial function in this patient category. Material and methods. It is planned to conduct a prospective randomized controlled trial, including 150 male patients aged 40-65 years, undergoing routine preventive examinations in the clinic of Moscow State University, having a high and very high risk of cardiovascular diseases and meeting the inclusion criteria. Group Pit (n=75) will receive pitavastatin at a starting dose of 1 mg/day. Group Ros (n=75) will receive rosuvastatin 20 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg/day a

Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of 150 participants across Russia shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• objective assessment of erectile function parameters (The assessment is carried out at the time of inclusion in the study, 3 and 6 months after the start of the study) — The relative increase in the diameter of the penis, the duration of the relative increase in the diameter of the penis is more than 20%, the duration of the relative increase in the diameter of the penis is more than 30%. The assessment is carried out using the Androscan nocturnal penile tumescence recorder.
• androgen status (The assessment is carried out at the time of inclusion in the study, 3 and 6 months after the start of the study) — Concentration of male sex hormones: testosterone, estradiol, dihydrotestosterone, sex hormone binding globulin.

Readout outlook and evidence gap

The current protocol points to 2027-12-01 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.

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Asset and sponsor context

Drug & Asset MCP profile: Pitavastatin Calcium is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.

Company & Deal Intelligence MCP profile: Moscow State University Lomonosov is resolved to a normalized organization record in Russia. The organization workflow adds identity, location, portfolio and partnering context where available.

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.

Bottom line

NCT07460960 provides a focused lens on Atherosclerosis development. Its value will be determined by whether Pitavastatin Calcium can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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