Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension

NCT07511361 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TLA-202
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently hospitalized and concurrently experienced an episode of acute severe hypertension.

Conditions

Hypertension; Acute Severe Hypertension; Hypertensive Emergency; Hypertensive Urgency

Outcome Measures

Primary Outcomes (2)

• Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptions

  * Change from baseline in plasma angiotensinogen (AGT) levels and systolic blood pressure * Variability in plasma AGT levels and systolic blood pressure

  Baseline through Week 12

• Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levels

  Percent change in plasma AGT levels from Baseline to Week 4

  Week 4

Secondary Outcomes (8)

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

  Week 36

• Part A: To assess the feasibility of using AGT levels and systolic blood pressure as efficacy endpoints

  Baseline through Week 12

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

  Week 36

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

  Week 4

• Part B: To evaluate the effect of tonlamarsen on office systolic blood pressure

  Week 4

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 with BMI ≤45.0 kg/m2
• Ready for discharge or recently discharged from the hospital to home (within the past 7 days) during which evaluation and/or treatment of acute severe hypertension (documented SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg) occurred, as measured by a healthcare provider (HCP) within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization
• At Screening and Randomization visit, average resting office systolic blood pressure ≥ 145 mmHg
• Presence of established cardiovascular or renal disease

You may not qualify if:

• Has known history of secondary hypertension
• Any malignancy requiring treatment within 5 years (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated)
• Has abnormal thyroid function with clinical significance
• Recent hospitalization for stroke, myocardial infarction or coronary revascularization within 30 days prior to screening
• 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 (8)

Western Nephrology and Metabolic Bone Disease, PC - Arvada

Arvada, Colorado, 80002, United States

RECRUITING

Homestead Associates in Research

Homestead, Florida, 33033, United States

RECRUITING

Progressive Medical Research

Port Orange, Florida, 32127, United States

RECRUITING

Richmond University Medical Center (RUMC)

Staten Island, New York, 10310, United States

RECRUITING

Research Innovations, LLC

Beavercreek, Ohio, 05431, United States

RECRUITING

Chattanooga Research & Medicine CHARM

Chattanooga, Tennessee, 37404, United States

RECRUITING

Laguna Clinical Research Associates

Laredo, Texas, 78041, United States

RECRUITING

Baylor Scott and White Research Institute - Temple

Temple, Texas, 76502, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Hypertensive Crisis

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 Two-Part study. Once eligibility is confirmed, eligible participants will then be randomized to tonlamarsen or placebo. The randomized treatment period will be followed by a 24-week safety follow-up period.

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 6, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)