Study of Efficacy and Safety of Tonlamarsen in Participants With Acute Severe Hypertension Recently Discharged From the Hospital

NCT07511361 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TLA-202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently discharged from the hospital, after treatment for acute severe hypertension.

Conditions

Hypertension; Acute Severe Hypertension

Outcome Measures

Primary Outcomes (2)

• To assess the effect of tonlamarsen on plasma angiotensinogen (AGT) levels

  Percent Change from baseline (Week 0) in plasma angiotensinogen (AGT) levels to Week 12

  Week 12

• To assess the systolic blood pressure-lowering effect of tonlamarsen

  Change from baseline (Week 0) in mean office seated systolic blood pressure to Week 12

  Week 12

Secondary Outcomes (2)

• To assess the safety and tolerability of tonlamarsen compared with placebo

  Week 20

• To evaluate the effect of tonlamarsen on systolic blood pressure measured via daily home blood pressure monitoring

  Week 12

Study Arms (2)

Tonlamarsen

EXPERIMENTAL

3 doses active drug will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks)

Drug: Tonlamarsen

Placebo

PLACEBO COMPARATOR

3 doses of placebo will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks)

Drug: Placebo

Interventions

Tonlamarsen DRUG

Tonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study

Tonlamarsen

Placebo DRUG

Placebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older, body weight ≥ 50 kg
• Recently discharged from the hospital to home within the past 3 days during which evaluation and/or treatment of acute severe hypertension (documented systolic blood pressure \>180 mmHg and/or diastolic \>110 mmHg) occurred, as measured by a healthcare provider within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization
• At Screening and Randomization visit, average systolic blood pressure \> 145 mmHg
• Presence of established cardiovascular or renal comorbidities

You may not qualify if:

• Has known history of secondary hypertension
• Any malignancy requiring treatment within 5 years
• Has abnormal thyroid function with clinical significance
• Recent hospitalization for stroke, type 1 myocardial infarction or coronary revascularization within 3 months prior to the first on-study visit
• History of and/or obvious clinical signs or symptoms of cirrhosis or other significant liver disease
• Alanine aminotransferase or aspartate aminotransferase \>2 x upper limit of normal
• Most recent hospitalization was for non-cardiovascular or non-renal conditions

Sponsors & Collaborators

• Kardigan, Inc.: lead

Study Sites (4)

Western Nephrology and Metabolic Bone Disease, PC - Arvada

Arvada, Colorado, 80002, United States

NOT YET RECRUITING

Homestead Associates in Research

Homestead, Florida, 33033, United States

RECRUITING

Progressive Medical Research

Port Orange, Florida, 32127, United States

RECRUITING

Chattanooga Research & Medicine CHARM

Chattanooga, Tennessee, 37404, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kardigan Clinical Study Information Team

CONTACT

+1-877-310-5135; clinicaltrials@kardigan.bio

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled, Multicenter study. Once eligibility is confirmed, eligible participants will then be randomized to tonlamarsen or placebo. The randomized treatment period will be followed by a 2-month safety follow-up period.

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 6, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): February 23, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)