Dutogliptin in Co-administration With Filgrastim in Early Recovery Post-myocardial Infarction

NCT ID: NCT05881382

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 4100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2025-09-30

Brief Summary

The goal of this phase 3, randomized, double-blind, placebo-controlled clinical trial is to explore the safety and efficacy of dutogliptin administered subcutaneously (SC) in co-administration with filgrastim in adult patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).

The primary objective is to evaluate the efficacy of dutogliptin compared with placebo in STEMI patients within 180 days of randomization measured by the time of first occurrence of a composite endpoint of cardiovascular (CV) death and worsening heart failure (HF) within 180 days. Participants will receive dutogliptin twice daily subcutaneously (SC) for 14 days and filgrastim (SC) daily for 5 days or placebo.

Conditions

ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dutogliptin + Filgrastim

Participants will receive BID SC injections of 60 mg dutogliptin for 14 days in co-administration with 10 µg/kg filgrastim for 5 days.

Group Type: ACTIVE_COMPARATOR

Dutogliptin + Filgrastim

Intervention Type: DRUG

dutogliptin twice daily subcutaneously for 14 days and filgrastim daily subcutaneously for 5 days.

Placebo-Dutogliptin + Placebo-Filgrastim

Randomized participants will receive BID SC injections of dutogliptin placebo for 14 days in co-administration with filgrastim placebo for 5 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo dutogliptin twice daily subcutaneously for 14 days and placebo filgrastim daily subcutaneously for 5 days.

Interventions

Dutogliptin + Filgrastim

dutogliptin twice daily subcutaneously for 14 days and filgrastim daily subcutaneously for 5 days.

Intervention Type: DRUG

Placebo

Placebo dutogliptin twice daily subcutaneously for 14 days and placebo filgrastim daily subcutaneously for 5 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female, age 18 to 85 years (having reached 18 years of age and before having reached 86 years of age at the time of ICF signing)

2. Able to provide written informed consent, including signing and dating the ICF

3. STEMI is defined as follows:

Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) AND

Anterior STEMI:

• ECG Criteria

• men > 40 years: ≥ 2 mm of new ST elevation in V2 and V3
• men ≤ 40 years: ≥ 2.5 mm of new ST elevation in V2 and V3
• women: ≥ 1.5 mm of new ST elevation in V2 and V3
• ECG Criteria

o ≥ 1 mm of new ST elevation in two contiguous leads 4. STEMI must meet one of the following criteria:

• Anterior STEMI with thrombolysis in myocardial infarction (TIMI) 0 or 1 flow at presentation
• Non-anterior MI with the following:

• TIMI 0 flow at presentation AND
• Signs of HF, defined as at least one of the following radiographic evidence of pulmonary congestion, peripheral edema, increased jugular venous pressure, hepatojugular reflux or both, third heart sound or gallop 6. Female patients of childbearing potential must have a negative serum pregnancy test at Screening and an additional negative urine pregnancy test prior to the first dose of IMP unless regulated differently by national legislation.

Exclusion Criteria

1. Known significant pre-existing cardiomyopathy, moderate or severe mitral disease or aortic valvular disease

2. Known pre-existing left ventricular ejection fraction < 40%

3. Existing heart transplant

4. Treatment with any dipeptidyl peptidase 4 (DPP4) inhibitors (eg, alogliptin, lingliptin, vildagliptin, saxagliptin, sitagliptin) or granulocyte colony-stimulation factor (G-CSF) medication (eg, filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim) within 4 months prior to randomization.

5. Contraindication to treatment with filgrastim, including known allergy to filgrastim or other G-CSF medication

6. Pregnant, planning to become pregnant, or nursing female patients

7. Known history of severe renal impairment or current renal impairment requiring dialysis

8. History of pancreatitis (induced by high doses of DPP-4 inhibitors)

9. Current or planned use of sulfonyl urea (risk of severe hypoglycemia)

10. Any clinically significant abnormality identified prior to randomization that in the judgement of the Investigator or Sponsor that would preclude safe completion of the study, or confound the anticipated benefit of dutogliptin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Recardio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

REC-DUT-003

Identifier Type: -

Identifier Source: org_study_id