NCT04867317 Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
| NCT ID | NCT04867317 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | VA Office of Research and Development |
| Condition | Adult Growth Hormone Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 172 participants in total. It began in 2025-01-13 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).
Eligibility Criteria
Inclusion Criteria: 1. OEF/OIF/OND Veteran 2. Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2) 3. Age 21 - 55 years old 4. One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey. 5. GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L), or glucagon stimulation test (cut point: 3 mcg/L for BMI up to 25; cut point 1 mcg/L for BMI 25 and above) and IGF-I lab values have to be less than or equal to +1 SDS at baseline 6. Score of 11 or more on QoL-AGHDA 7. 4-week stability on any psychotropic medications 8. 3-month stability on all other hormone treatments 9. Able and willing to provide informed consent to participate in this study, and complete study protocol. Exclusion Criteria: 1. History of moderate or severe TBI 2. History of neurologic disorder other than TBI with substantial impact on quality of life 3. History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder 4. Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months. 5. Contraindication to rhGH therapy 6. Acute medical illness, active infection, cancer or decompensated chronic medical illness 7. Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed. 8. Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory and Malingering (TOMM). 9. BMI \> 40 or body weight \> 350 lbs 10. Pituitary anatomy documented by an MRI using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass) 11. Women who are pregnant or of child-bearing potential not on contraception 12. Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses 13. Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)
Contact & Investigator
Jose M. Garcia, MD PhD
STUDY CHAIR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Frequently Asked Questions
Who can join the NCT04867317 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 55 Years, studying Adult Growth Hormone Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04867317 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 172 participants.
Is NCT04867317 currently recruiting?
Yes, NCT04867317 is actively recruiting participants. Contact the research team at Deane.Walker@va.gov for enrollment information.
Where is the NCT04867317 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, San Diego, United States, Aurora, United States and 11 additional locations.
Who is sponsoring the NCT04867317 clinical trial?
NCT04867317 is sponsored by VA Office of Research and Development. The principal investigator is Jose M. Garcia, MD PhD at VA Puget Sound Health Care System Seattle Division, Seattle, WA. The trial plans to enroll 172 participants.