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Active Not RecruitingPhase 2NCT05919147
Official study title

The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia

Study summary

The goal of this clinical trial is evaluate the effect of pioglitazone compared with placebo on skeletal muscle insulin sensitivity in subjects with cancer and cachexia.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedPioglitazone 45 mg and Placebo

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 4, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Pennington Biomedical Research Center

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Phase 2
Sponsor
Pennington Biomedical Research Center
Interventions being studied
Drug: Pioglitazone 45 mg; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Age ≥18 years
  • Documented histologic or cytologic diagnosis of non-small-cell lung cancer or gastrointestinal cancer that is locally advanced and inoperable or metastatic (e.g., spread to distant organs)
  • Cachexia defined by Fearon criteria
  • Insulin resistance syndrome, defined with the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
  • Ability to provide written informed consent, willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Provide written approval by a qualified healthcare professional
  • Allow the collection and storage of biospecimens and data for future use
Reasons someone may not be able to joinExclusion criteria
  • Prior diagnosis of type 2 diabetes
  • Prior or current thiazolidinedione (TZD) therapy
  • Known hypersensitivity to TZD
  • New York Heart Association (NYHA) class I-IV heart failure
  • History of or actively treated bladder cancer
  • Current use of CYP2C inhibitor (e.g., gemfibrozil) or CYP2C inducer (e.g., rifampin)
  • Inadequate hepatic function
  • Currently pregnant, breastfeeding, or planning to become pregnant within the next 16 weeks
  • Contraindications to magnetic resonance imaging (e.g., implanted cardiac device, cochlear implant)
  • Any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Pennington Biomedical Research CenterBaton Rouge, Louisiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 4, 2025. Always confirm current availability with the study team.

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