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

NCT05881382 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: REC-DUT-003
• Study Type: interventional
• Target: 4,100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time of first occurence of the following composite endpoint of cardiovascular (CV) death and worsening of heart failure (HF)

  defined as either an unplanned hospitalization or urgent visit resulting in intravenous therapy for heart failure

  within 180 days of randomization

Secondary Outcomes (3)

• Time to cardiovascular death

  within 180 days of randomization

• Worsening heart failure

  within 180 days of randomization

• Total symptom score of the Kansas City Cardiomyopathy Questionnaire

  at 180 days

Study Arms (2)

Dutogliptin + Filgrastim

ACTIVE COMPARATOR

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

Drug: Dutogliptin + Filgrastim

Placebo-Dutogliptin + Placebo-Filgrastim

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dutogliptin + Filgrastim DRUG

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

Dutogliptin + Filgrastim

Placebo DRUG

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

Placebo-Dutogliptin + Placebo-Filgrastim

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Known significant pre-existing cardiomyopathy, moderate or severe mitral disease or aortic valvular disease
• Known pre-existing left ventricular ejection fraction \< 40%
• Existing heart transplant
• 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.
• Contraindication to treatment with filgrastim, including known allergy to filgrastim or other G-CSF medication
• Pregnant, planning to become pregnant, or nursing female patients
• Known history of severe renal impairment or current renal impairment requiring dialysis
• History of pancreatitis (induced by high doses of DPP-4 inhibitors)
• Current or planned use of sulfonyl urea (risk of severe hypoglycemia)
• 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

Sponsors & Collaborators

• Recardio, Inc.: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

dutogliptin; Filgrastim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 5, 2023

Record last verified: 2023-06