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New combo drug aims to tackle high cholesterol in one daily pill

NCT ID NCT03527069

Disease control Sponsor: EMS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested a new combination drug called Cipros 10 against the standard statin Crestor in 146 adults with dyslipidemia (high cholesterol and triglycerides). The goal was to see if Cipros 10 could lower triglyceride levels more effectively. Participants took one pill daily, and researchers tracked both lab results and any side effects.

What this could mean

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

Active substance
Cipros 10 (a combination drug containing rosuvastatin and other agents)
What this could lead to
If successful, this could offer a new once-daily pill option to help control high triglycerides and cholesterol.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove significantly better than existing statins like Crestor, and side effects are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

146 people

The number who actually took part.

Started

Jan 2021

Finished

Jul 2025

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 years and older

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: * Participants of both sexes, aged 18 years or more; * Participants with the diagnosis of Dyslipidemia presentinf low or intermediate cardiovascular risk, according to the Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis; * Signed consent. Exclusion Criteria: * Diagnosis of familial hypercholesterolemia and other genetic diseases; * Using medications that may interfere with the metabolism or serum levels of triglycerides; * Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * Presence of concomitant cardiovascular disease, renal failure and hepatic Failure; * Decompensated diabetes; * Current smoking; * History hypersensitivity to the active ingredients used in the study; * Pregnancy or risk of pregnancy and lactating patients; * History of alcohol abuse or illicit drug use; * Participation in clinical trial in the year prior to this study.

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Conditions

The condition(s) this trial relates to.

Dyslipidemias hypertriglyceridemia inherited lipid metabolism disorder

As listed by the trial registrant

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

Dyslipidemia Hypertriglyceridemia

Contacts and locations

Locations

  • Allergisa

    Campinas, São Paulo, Brazil

More trials for these conditions

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