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New injection shows promise for lowering cholesterol in indian patients

NCT ID NCT06386419

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the safety and effectiveness of inclisiran sodium, a cholesterol-lowering injection, in 65 Indian adults with high cholesterol or mixed dyslipidemia. Participants received three doses over 270 days. The goal was to see how well it lowers LDL cholesterol and if any side effects occur.

What this could mean

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

Active substance
inclisiran sodium
What this could lead to
If successful, this could confirm that inclisiran is a safe and effective option for lowering cholesterol in Indian patients, offering a convenient injection schedule.
What could go wrong
This is a small, completed Phase 4 study with only 65 participants, so results may not apply to everyone. Side effects or lack of effectiveness 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

65 people

The number who actually took part.

Started

Nov 2024

Finished

Jan 2026

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 100 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: 1. Male and female Indian participants aged ≥18 years or older. 2. Participants for whom the treating physician prescribes treatment with inclisiran sodium in adherence with the India PI i.e., patients who are diagnosed with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet: 1. in combination with a statin or statin with other LLTs in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or 2. alone or in combination with other LLTs in patients who are intolerant to statins or for whom a statin is contraindicated. 3. Participants on LLTs should be on a stable dose for ≥30 days before the first dose administration of the study treatment. Exclusion Criteria: 1. Any surgical and/or medical condition, which in the opinion of the treating physician, may place the participant at higher risk of his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study. 2. Participants who have previous exposure to inclisiran sodium. 3. Pregnant or nursing (lactating) women.

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Conditions

The condition(s) this trial relates to.

hyperlipidemia, familial combined, LPL related

As listed by the trial registrant

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

Mixed dyslipidemia Primary hypercholesterolemia

Contacts and locations

Locations

  • Novartis Investigative Site

    Bangalore, Karnataka, 560099, India

  • Novartis Investigative Site

    Belagavi, Karnataka, 590010, India

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400012, India

  • Novartis Investigative Site

    Nagpur, Maharashtra, 441108, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302039, India

  • Novartis Investigative Site

    Madurai, Tamil Nadu, 625107, India

  • Novartis Investigative Site

    Vellore, Tamil Nadu, 632 004, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700 020, India

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