The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia

NCT05919147 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: PBRC 2023-013
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Change in skeletal muscle insulin sensitivity

  Quantified using hyperinsulinemic-euglycemic clamp

  Baseline, Week 12

Study Arms (2)

Pioglitazone

EXPERIMENTAL

Drug: Pioglitazone 45 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pioglitazone 45 mg DRUG

The dose of pioglitazone will not exceed 45 mg once daily. Pioglitazone dose will titrate progressively over the first three weeks.

Pioglitazone

Placebo DRUG

Placebo will have the same appearance as the active drug.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 26, 2023
• Study Start: January 3, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)