A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

An Exploratory, Randomised, Double-blind, Multicentre, Placebo-controlled Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)

This is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026.

The study population will consist of men and women with documented evidence of ST-elevation myocardial infarction (STEMI) referred to primary Percutaneous Coronary Intervention (PCI).

Study Overview

• Status: Recruiting
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Drug: RTP-026; Drug: Placebo

Detailed Description

An exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026 to assess safety, tolerability, and efficacy in patients with (STEMI).

The study population is men between 18-85 years and post-menopausal women up to 85 years with documented evidence of STEMI referred to primary PCI with acute onset of chest pain lasting <12 hours and neutrophil to lymphocyte ratio (NLR) in the range of 3-17 at hospital admission (Please refer to inclusion criteria).

The participants will be given three 30-minute intravenous infusions of RTP-026 or placebo (the investigational product). The first dose is to be initiated within 2 hours following the establishment of reflow after PCI, and the following two study treatments with 8-hour intervals.

The purpose of this study is to evaluate the safety, tolerability and efficacy of RTP-026 versus placebo in multiple doses.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Irene Sandholdt; Phone Number: +45 2015 7033; Email: isa@croxxmed.com
• Study Contact Backup: Name: Samra J Sanni, PhD; Phone Number: +45 3120 8857; Email: sas@resotherpharma.com

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Hjertecenteret, Rigshospitalet
    • Contact: Thomas Engstrøm, Prof. MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent for participation in the study has been obtained prior to initiating any study-specific procedures
• Men between 18-85 years of age and post-menopausal women up to 85 years of age
• Acute onset of chest pain of < 12 hours duration
• STEMI as characterized on ECG by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with a minimum of 1 mm concordant ST elevation or 1 mV ST elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior acute myocardial infarction (AMI)
• Eligible for primary PCI
• NLR in the range of 7-17 at hospital admission. In patients with chest pain lasting > 3 - ≤ 6 hours at admission, the NLR should be in the range of 4.8-17 and for patients with chest pain lasting ≤ 3 hours at admission, the NLR should be in the range of 4.8-17, or the neutrophile count should be ≥ 9 x 10E9/L, irrespective of the lymphocyte count. For STEMI patients with an anterior or anterolateral infarction, the NLR should be ≥3.

Exclusion Criteria:

• Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
• Previous exposure to RTP-026
• Time from symptoms onset to primary PCI > 12 hours
• Previous CABG
• Evidence of active malignant disease
• Ongoing treatment with immune suppressive compounds
• Any condition that, in the view of the investigator, would suggest that the patient is unable to comply with the study protocol and procedures
• Known contraindications to CMR
• ORBI Risk Score > 12

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo	Drug: Placebo; Intervention is for each subject administered as three 30-minutes infusions of placebo
Experimental: RTP-026	Drug: RTP-026; Intervention is for each subject administered as three 30-minutes infusions of either A: 25μg/kg RTP-026; or B: ≥ 26μg/kg and ≤75μg/kg RTP-026; or C: A maximum of 3 x treatment dose RTP-026 as given in B;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cardiac Troponin T (cTNT)	Change in cTnT determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI.	24 hours
Change in Creatinine kinase-MB (CK-MB)	Change in CK-MB determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI.	24 hours

Collaborators and Investigators

• Sponsor: ResoTher Pharma
• Investigators: Principal Investigator: Thomas Engstrøm, Prof. MD, Hjertecenteret, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Estimated): December 21, 2025
• Study Completion (Estimated): December 21, 2025

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction
• Other Study ID Numbers: ResoTher-CS002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No