NCT05919147Active, not recruitingPhase 2
The Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Neuroendocrine Effects of Pioglitazone in Patients With Cancer and Cachexia
Source: ClinicalTrials.gov · Last updated 4 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 12 Jun 2023
- Start date
- 3 Jan 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Pennington Biomedical Research Center
- Diseases
- Lung cancer
- NCT number
- NCT05919147
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- From 3 Jan 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis of type 2 diabetes
- Prior or current thiazolidinedione (TZD) therapy
- Current use of CYP2C inhibitor (e.g., gemfibrozil) or CYP2C inducer (e.g., rifampin)
Other illness
- Known hypersensitivity to TZD
- New York Heart Association (NYHA) class I-IV heart failure
- History of or actively treated bladder cancer
- 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
Other
- Inadequate hepatic function
- Currently pregnant, breastfeeding, or planning to become pregnant within the next 16 weeks
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.