Adult Growth Hormone DeficiencyPhase 3GRITNCT04867317
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
A Phase 3 study testing Somatropin in people with Adult Growth Hormone Deficiency and Mild Traumatic Brain Injury, run by VA Office of Research and Development at 16 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
- What is being tested?
- Somatropin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 16 sitesUnited States
- Study dates
- 13 Jan 2025to 30 Sep 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- OEF/OIF/OND Veteran
- Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
- One or more mild traumatic brain injury (mTBI) sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey.
- Growth hormone (GH) deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 micrograms per liter), or glucagon stimulation test (cut point: 3 micrograms per liter (mcg/L) for body mass index up to 25; cut point 1 micrograms per liter for body mass index (BMI) 25 and above) and IGF-I lab values have to be less than or equal to +1 SDS at baseline
- Score of 11 or more on QoL-AGHDA
- 4-week stability on any psychotropic medications
- 3-month stability on all other hormone treatments
- Able and willing to provide informed consent to participate in this study, and complete study protocol
Who cannot join
- History of moderate or severe traumatic brain injury (TBI)
- History of neurologic disorder other than traumatic brain injury with substantial impact on quality of life
- History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder
- 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.
- Contraindication to recombinant human growth hormone (rhGH) therapy
- Acute medical illness, active infection, cancer or decompensated chronic medical illness
Show all 13Show fewer
- 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.
- Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory and Malingering (TOMM).
- body mass index (BMI) > 40 or body weight > 350 pounds
- 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)
- Women who are pregnant or of child-bearing potential not on contraception
- Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses
- Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 15 recruiting
- Recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Richard J Auchus, MD, Richard.Auchus@va.gov
Percival Pangilinan, MD, PERCIVAL.PANGILINAN@va.gov
- Recruiting
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Lisa Brenner, PhD, Lisa.Brenner@va.gov
Salwa Zahalka, MD, Salwa.Zahalka2@va.gov
- Not yet recruiting
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233-1927
Ripu Jindal, MD, Ripu.Jindal@va.gov
Emily Schlitz, MD, Emily.Schlitz@va.gov
- Not yet recruiting
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Kyaw Soe, MD, kyaw.Soe@va.gov
Weibin Yang, MD, Weibin.Yang@va.gov
- Active, not recruiting
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
- Recruiting
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Sanjay Mediwala, MD, 713-791-1414, Sanjay.Mediwala@va.gov
Dakota Broadway, 7137948601, Dakota.Broadway@va.gov
- Not yet recruiting
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, 64128-2226
Mariana Garcia-Touza, MD, Mariana.Garcia-Touza@va.gov
Vikas Singh, MD, Vikas.Singh3@va.gov
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Shalamar Sibley, MD, 612-725-2000 ext. 4424, Shalamar.Sibley@va.gov
Naomi Scott, PsyD, 6124675447, Naomi.Scott@va.gov
- Not yet recruiting
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, 73104-5007
Calin Prodan, MD, Calin.Prodan@va.gov
Robert Scofield, MD, Robert.Scofield@va.gov
- Not yet recruiting
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850
Cyrus V DeSouza, MBBS, Cyrus.DeSouza@va.gov
Daniel Pierce, MD, Daniel.Pierce3@va.gov
- Not yet recruiting
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
Sherman Harman, MD, Sherman.Harman@va.gov
Steven F Werder, DO, Steven.Werder@va.gov
- Not yet recruiting
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, 28144
Robin hurley, MD, robin.hurley@va.gov
Donald Mcclain, DO, Donald.Mcclain@va.gov
- Not yet recruiting
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229-4404
Devjit Tripathy, MD, Devjit.Tripathy2@va.gov
Gustavo Armaiz-Pena, MD, Gustavo.ArmaizPena@va.gov
- Not yet recruiting
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Richard L Hauger, MD, Richard.Hauger@va.gov
Christopher Hupfeld, MD, Christopher.Hupfeld@va.gov
- Recruiting
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
Megan M Herodes, BS, (206) 764-2984, Megan.Herodes@va.gov
Audri Villalon, MPH, (713) 791-1414 ext. 28517, Audri.Villalon@va.gov
- Not yet recruiting
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422-0001
Sen Sabyasachi, MD, Sabyasachi.Sen@va.gov
About this study
Official title: CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
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).
- Being tested
- Somatropin, Placebo
- Medical subject headings
- Dwarfism, Pituitary, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone Replacement Therapy | Active comparator | Recombinant Human Growth Hormone Receives: Drug: Somatropin |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults)
25 question survey on quality of life; The primary objective of CSP #2018 is to determine the efficacy of rhGH, given daily for 6 months, versus placebo to improve QoL, as measured by difference in mean QoL-AGHDA score, among Veterans with a history of mTBI and AGHD (primary outcome). The primary hypothesis is that the investigators, compared to placebo, patients treated with rhGH will exhibit a 3.5-point lower mean score (higher quality of life) in QoL-AGHDA at 6 months. QoL-AGHDA: minimum score=0 (high QoL: best outcome); maximum score=25 (low QoL: worst outcome).
Measured: 6 months
Secondary outcomes (1)
Body Composition
DEXA (Dual-Energy x-ray absorptiometry); The secondary objective of CSP #2018 is to investigate the efficacy of rhGH vs placebo on long-term surrogate outcomes: a) body composition, assessed through dual-energy x-ray absorptiometry (DEXA) and b) cardiometabolic risk factors including lipids, autonomic function, and highly sensitive C-reactive protein. The specific hypotheses for these outcomes are that compared to placebo there will be a 4.5% mean reduction in total truncal body fat percentage and a mean reduction of 10 mg/dL in LDL serum levels after 6 months of treatment and follow-up of rhGH.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start13 Jan 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm study: active drug vs placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jose M. Garcia, MD PhD, Study chair, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867317
- Sponsor's protocol ID
- 2018
- Other IDs
- 2018
- Acronym
- GRIT
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (VA-CSP). These data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible.