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

NCT06465303 | Recruiting Phase 2 DMC

• 1 other identifier: ResoTher-CS002
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

RTP-026

EXPERIMENTAL

Drug: RTP-026

Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

RTP-026 DRUG

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;

RTP-026

Placebo DRUG

Intervention is for each subject administered as three 30-minutes infusions of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ResoTher Pharma: lead

Study Sites (1)

Hjertecenteret, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Thomas Engstrøm, Prof. MD

  Hjertecenteret, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Sandholdt

CONTACT

+45 2015 7033; isa@croxxmed.com

Samra J Sanni, PhD

CONTACT

+45 3120 8857; sas@resotherpharma.com

Study Design

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

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: July 16, 2024
• Primary Completion: December 21, 2025
• Study Completion: December 21, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)