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RNAi Therapeutics

ALN-AGT01 for High Blood Pressure (KARDIA-1 Trial)

Phase 2

Waitlist Available

Research Sponsored by Alnylam Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Daytime mean SBP ≥135 mmHg and ≤160 mmHg by ABPM, without antihypertensive medication

Be older than 18 years old

Must not have

Newly diagnosed Type 2 diabetes mellitus

Type 1 diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a drug to see if it can lower blood pressure. They will also be looking at the drug's safety and how it affects the body.

Who is the study for?

This trial is for adults with mild to moderate high blood pressure, specifically those with a daytime mean systolic blood pressure between 135 and 160 mmHg without medication. It's not for people with high potassium levels, severe kidney issues, uncontrolled or new Type 2 diabetes, recent heart events, Type 1 diabetes, intolerance to injections under the skin (subcutaneous), secondary hypertension, drops in blood pressure upon standing (orthostatic hypotension), or certain liver enzyme elevations.

What is being tested?

The KARDIA-1 study is testing ALN-AGT01 against a placebo to see its effects on lowering both the top (systolic) and bottom (diastolic) numbers in blood pressure readings. The trial will also look at how the body responds to this drug and its safety profile.

What are the potential side effects?

While specific side effects of ALN-AGT01 are not listed here, common ones may include reactions at the injection site since it's given under the skin. Other potential side effects could be related to changes in kidney function or electrolyte imbalances due to its effect on blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My average daytime blood pressure is between 135 and 160 mmHg without medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have recently been diagnosed with Type 2 diabetes.

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I have Type 1 diabetes.

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My kidney function is low, with an eGFR of 30 or less.

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My Type 2 diabetes is not well-managed.

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My high blood pressure is caused by another health condition.

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I experience significant drops in blood pressure when standing up.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: ALN-AGT01 Dose Regimen 4Experimental Treatment1 Intervention

Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.

Group II: ALN-AGT01 Dose Regimen 3Experimental Treatment1 Intervention

Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.

Group III: ALN-AGT01 Dose Regimen 2Experimental Treatment1 Intervention

Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.

Group IV: ALN-AGT01 Dose Regimen 1Experimental Treatment1 Intervention

Multiple doses of ALN-AGT01 administered by subcutaneous (SC) injection during the 12-month DB treatment period.

Group V: Placebo + ALN-AGT01Placebo Group2 Interventions

Multiple doses of placebo administered by SC injection during the first 6 months of 12-month DB treatment period, followed by multiple doses of ALN-AGT01 administered by SC injection during the last 6 months of the 12-month DB treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ALN-AGT01

2019

Completed Phase 1

~130

0 / 7Eligibility criteria met