Recruiting
Phase 3

Growth Hormone

Sponsor:

VA Office of Research and Development

Code:

NCT04867317

Conditions

Adult Growth Hormone Deficiency

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Not accepted

Interventions

Somatropin

Placebo

Study Details

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).

Conditions

Adult Growth Hormone Deficiency

Mild Traumatic Brain Injury

Study ID

NCT04867317

Start date

Jan 13, 2025

Status verified date

Jul, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

172 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Growth Hormone Replacement Therapy

Recombinant Human Growth Hormone

placebo comparator: Placebo

Placebo

Interventions

Somatropin

Participants (n=172) will be randomized in a 1:1 ratio to rhGH (n=86) versus placebo (n=86) for six months, stratified by participating site. Both study participants and the study team will be blinded to treatment assignment. All participants will complete in-clinic follow-ups at Days 14, 40, 65, and 90 (3 months) and at day 180 (6 months). The primary outcome will be the mean difference in QoL-AGHDA scores between treatment arms at 6 months follow-up. Patients will discontinue the study intervention at 6 months, and will be followed-up two weeks subsequent, in order to assure patient safety and wellness, and to ensure maximal facilitation of patient transition back into routine care.

Placebo

Participants (n=172) will be randomized in a 1:1 ratio to rhGH (n=86) versus placebo (n=86) for six months, stratified by participating site. Both study participants and the study team will be blinded to treatment assignment. All participants will complete in-clinic follow-ups at Days 14, 40, 65, and 90 (3 months) and at day 180 (6 months). The primary outcome will be the mean difference in QoL-AGHDA scores between treatment arms at 6 months follow-up. Patients will discontinue the study intervention at 6 months, and will be followed-up two weeks subsequent, in order to assure patient safety and wellness, and to ensure maximal facilitation of patient transition back into routine care.

Primary outcome measure

  • QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Deane V Walker, MHA BS AB

(203) 937-3440Deane.Walker@va.gov

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Recruiting

Seattle, Washington, United States, 98108-1532

Contacts

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-09.