New Drug UDP-003 Safely Clears Toxic Cholesterol Behind Artery Plaques in Phase 1 Trial
Cyclarity's UDP-003 passed its first human trial with zero serious side effects, successfully flushing toxic 7-ketocholesterol through urine.
Summary
Cyclarity's experimental drug UDP-003 has completed a successful Phase 1 trial in 72 healthy volunteers in Australia. The drug targets 7-ketocholesterol (7KC), a toxic oxidized cholesterol that accumulates inside artery plaques and drives atherosclerosis. Unlike standard cardiovascular drugs that lower LDL or reduce inflammation, UDP-003 is designed to grab 7KC directly and remove it from the body through urine. The trial showed no serious adverse events, no dropouts, and clean pharmacokinetics — the drug passes through the body unchanged within three hours. Crucially, participants excreted measurable 7KC in urine for the first time, with a clear dose-response relationship. Researchers now plan to advance to Phase 2 testing in actual atherosclerosis patients at the highest tested dose.
Detailed Summary
Atherosclerosis — the buildup of arterial plaques — remains the leading cause of heart attack and stroke worldwide. Most approved therapies target LDL cholesterol or inflammation, but they do not address a key driver of plaque toxicity: 7-ketocholesterol (7KC), an oxidized form of cholesterol that accumulates inside macrophages, converting them into dysfunctional foam cells that clog and harden arteries. Cyclarity Therapeutics has developed UDP-003 specifically to intercept and remove 7KC.
The Phase 1 trial, conducted at CMAX clinical research center in Australia under the Victorian Heart Institute and cardiologist Dr. Steve Nichols, enrolled 72 healthy adult volunteers. It tested escalating doses of UDP-003 to establish safety and observe what the drug does inside the human body. Results across all three primary endpoints were described as better than expected by Cyclarity CEO Dr. Matthew O'Connor.
On safety, UDP-003 showed no serious adverse events at any dose level, with no participants withdrawing due to side effects. The drug reached its maximum tested dose without triggering safety halts — a critical milestone that clears the path to Phase 2 patient trials. On pharmacokinetics, the compound was not metabolized at all; it circulated briefly and was excreted completely via urine within three hours, exactly as designed.
Most significantly, UDP-003 demonstrated clear target engagement. Participants excreted measurable 7KC in urine — something that does not occur naturally — with a precise dose-response curve: higher doses produced proportionally more 7KC excretion. This suggests the drug is actively sequestering the toxic molecule and removing it from the body.
The next step is a Phase 2 trial in patients with confirmed atherosclerosis, testing whether 7KC clearance translates into measurable plaque reduction or cardiovascular risk improvement. While Phase 1 results are promising, efficacy in disease populations remains unproven. Independent peer-reviewed publication of the full trial data is still pending.
Key Findings
- UDP-003 showed zero serious adverse events across all dose levels in 72 healthy human volunteers.
- The drug is excreted unchanged through urine within 3 hours, suggesting a clean safety and metabolism profile.
- Participants urinated measurable 7-ketocholesterol for the first time, confirming direct target engagement.
- A clear dose-response relationship was observed: higher doses removed proportionally more toxic 7KC.
- Phase 2 trials in atherosclerosis patients will now proceed at the highest tested dose.
Methodology
This is a news interview/report published by Lifespan.io based on direct conversation with Cyclarity's CEO Dr. Matthew O'Connor. It summarizes unpublished Phase 1 trial results; no peer-reviewed paper is cited. Source credibility is moderate — Lifespan.io is a respected longevity-focused outlet, but data should be verified against future published trial results.
Study Limitations
Trial results come from a company spokesperson, not a peer-reviewed publication, so independent verification is not yet possible. The study was conducted in healthy volunteers, not atherosclerosis patients, so therapeutic efficacy remains undemonstrated. Full statistical data, adverse event rates, and methodology have not been publicly disclosed in detail.
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