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One shot to tackle two heart risks? new combo drug enters human trials

NCT ID NCT07610278

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This Phase 2 trial tests a new drug called HDY015, which combines two medicines (QCZ484 and inclisiran) into a single injection. The goal is to see if it can safely lower both blood pressure and cholesterol in people who have both conditions. About 120 adults aged 18-75 with hypertension and high cholesterol will receive either the combo, one of the drugs alone, or a placebo, and be followed for 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HDY015 (a combination of QCZ484 and inclisiran)
What this could lead to
If successful, this could lead to a single-dose treatment that controls both high blood pressure and high cholesterol, reducing the need for multiple daily pills.
What could go wrong
This is an early Phase 2 study with only 120 participants, so results may not apply to everyone. The combination may cause side effects or not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males or females aged 18 to 75 years. * Diagnosis of primary hypertension. * Treatment with either no, or up to 2 antihypertensive medications at a stable dose for at least 4 weeks preceding screening. * Systolic blood pressure ≥140 and \<165 mmHg based on the mean of 3 sitting measurements based on office blood pressure monitoring. * Diagnosis of hypercholesterolemia including heterozygous familial hypercholesterolemia unable to reach LDL-C goals with a stable dose of statin treatment for at least 4 weeks prior to screening as per Investigator judgement, guidelines and local practice (if tolerated and not contraindicated) with or without bempedoic acid and with or without ezetimibe prescribed according to local guidance, at a stable dose for at least 4 weeks preceding Screening Visit 1. The following parameters must be confirmed at Screening Visit 2: * Fasting serum LDL-C ≥70 mg/dL and \<190 mg/dL using Friedewald equation. * Fasting triglyceride \<400 mg/dL. Exclusion Criteria: * Symptomatic orthostatic hypotension. * Treatment with certain medications and/or unable to comply with prohibited medications requirements. Other protocol inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

essential hypertension Hypercholesterolemia hypercholesterolemia, familial, 1 hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypercholesterolaemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    29 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ALL Medical Research LLC

    RECRUITING

    Cooper City, Florida, 33024, United States

  • AMR Chicago

    RECRUITING

    Niles, Illinois, 60714, United States

  • AMR Miami

    RECRUITING

    Coral Gables, Florida, 33134, United States

  • Alliance for Multispecialty Research

    RECRUITING

    Wichita, Kansas, 67207, United States

  • American Research Centers of FL

    RECRUITING

    Pembroke Pines, Florida, 33027, United States

  • Anderson Medical Research

    RECRUITING

    Ft. Washington, Maryland, 20744, United States

    Contact Email: •••••@•••••

  • Capitol Cardiology Associates

    RECRUITING

    Lanham, Maryland, 20706, United States

  • Clinical Research of Brandon LLC

    RECRUITING

    Brandon, Florida, 33511, United States

  • Clinical Trials Research

    RECRUITING

    Lincoln, California, 95648, United States

  • Dominion Medical Associates

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Downtown L A Research Center Inc

    RECRUITING

    Los Angeles, California, 90017, United States

  • East Coast Inst for Research LLC

    RECRUITING

    Saint Augustine, Florida, 32086, United States

  • East Coast Institute for Research

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • East Coast Research

    RECRUITING

    Canton, Georgia, 30114, United States

  • Entrust Clinical Research

    RECRUITING

    Miami, Florida, 33176, United States

  • Flourish Medical Clinical Trials

    RECRUITING

    Boca Raton, Florida, 33434, United States

  • G and L Research LLC

    RECRUITING

    Foley, Alabama, 36535, United States

    Contact Email: •••••@•••••

  • Great Lakes Clinical Trials

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Inpatient Research Clinical LLC

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Inpatient Research Clinical LLC

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Manassas Clinical Research Center

    RECRUITING

    Manassas, Virginia, 20110, United States

  • Monroe Biomedical Research

    RECRUITING

    Monroe, North Carolina, 28112, United States

  • Monroe Research Llc

    RECRUITING

    West Monroe, Louisiana, 71291, United States

  • Synergy Group Medical LLC

    RECRUITING

    Houston, Texas, 77061, United States

  • Synergy Group Medical LLC

    RECRUITING

    Houston, Texas, 77061, United States

  • The Center for Clinical Trials

    RECRUITING

    Saraland, Alabama, 36571, United States

  • Universal Axon Clinical Research

    RECRUITING

    Doral, Florida, 33166, United States

  • Valley Clinical Trials

    RECRUITING

    Northridge, California, 91325, United States

  • Walker Family Care

    RECRUITING

    Little River, South Carolina, 29566, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.