Growth Hormone DeficiencyPhase 2OraGrowtH210NCT04614337
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
A Phase 2 study testing LUM-201 and rhGH Norditropin® pen (34 µg/kg) in people with Growth Hormone Deficiency, run by Lumos Pharma at 43 sites in 6 countries.
Trial summary
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- LUM-201 and rhGH Norditropin® pen (34 µg/kg)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 43 sitesin 6 countries
- Study dates
- 31 Dec 2020to 4 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have an established diagnosis of idiopathic PGHD as determined by standard diagnostic criteria. Eligible subjects must be naïve-to-treatment and be prepubertal.
- Morning cortisol ≥ 7 µg/dL or stimulated cortisol ≥ 14 µg/dL.
- At Screening, be ≥ 3.0 years and ≤ 11.0 years for girls and ≤ 12.0 years for boys.
- Have HT-SDS ≤ -2.0 or HT-SDS ≥ 2 SD below mean parental HT-SDS.
- Have a baseline height velocity < 5.5 cm/year based on at least 6 months of growth.
- Have a bone age delayed by ≥ 6 months with respect to chronological age.
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- Have prepubertal status as evidenced by Tanner Stage I breast development in girls and testicular volume < 4.0 mL in boys.
- In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic testing results are available, they need to be negative.
- Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 30 days prior to Day 1.
Who cannot join
- Any medical or genetic condition which, in the opinion of the Investigator or Medical Monitor (MM), can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment. (Examples: diabetes, idiopathic short stature).
- A medical or genetic condition that, in the opinion of the Investigator and/or MM, adds unwarranted risk to use of LUM-201 or rhGH.
- Use of any medication that, in the opinion of the Investigator and/or MM, can independently cause short stature or limit the response to exogenous growth factors (Example: glucocorticoids).
- Evidence or history of an intracranial mass (e.g., pituitary tumor, craniopharyngioma).
- Suspicion of absent pituitary function as evidenced by a maximal stimulated GH ≤ 3 ng/mL on two prior standard of care GH stimulation tests, or pituitary deficiencies beyond GH and thyroid function.
- Malnutrition as evidenced by medical history or a body weight < 3rdth percentile for current height.
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- BMI > 95th percentile.
- Gestational age-adjusted birth weight < 5th percentile (small for gestational age).
- History of spinal, cranial, or total body irradiation.
- Treatment with medications known to act as moderate or strong inhibitors or strong inducers of CYP3A/4, or with medications known to act as strong inhibitors of P-glycoprotein (P-gp) or potent substrates of P-gp or Multidrug and toxin extrusion protein 1 (MATE1).
Trial locations and contacts
43 sites in 6 countries.
43 sites in 6 countries
United States27 sites
Texas Tech University Health Sciences Center
Amarillo, Texas, 79106
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
UBMD Pediatrics
Buffalo, New York, 14203
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Health System
Charlottesville, Virginia, 22908
Nationwide Children's Hospital
Columbus, Ohio, 43205
Cook Children's Medical Center
Fort Worth, Texas, 76104
Pediatric Endocrine Associates
Greenwood Village, Colorado, 80111
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
The Children's Mercy Hospital
Kansas City, Missouri, 64111
Novak Center For Childrens Health
Louisville, Kentucky, 40202
M Health, Fairview Pediatric Specialty Clinics- Discovery Clinic
Minneapolis, Minnesota, 55454
The Mount Sinai Hospital
Mount Sinai, New York, 30093
NYU Grossman School of Medicine
New York, New York, 10016
University of Oklahoma Health Sciences Center, Pediatric Diabetes and Endocrinology
Oklahoma City, Oklahoma, 73104
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Center of Excellence in Diabetes and Endocrinology
Sacramento, California, 95821
Children's Minnesota
Saint Paul, Minnesota, 55102
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Rady Children's Hospital
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405
Children's National Hospital
Washington D.C., District of Columbia, 20010
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Poland8 sites
Klinika Pediatrii, Endokrynologii, Diabetologii z Pododdziałem Kardiologii, Uniwersytecki Dziecięcy Szpital Kliniczny im.Ludwika Zamenhofa w Białymstoku
Bialystok
Klinika Endokrynologii i Chorob Metabolicznych, Instytut Centrum Zdrowia Matki Polki
Lodz
Klinika Pediatrii, Diabetologii i Endokrynologii Gdansk
Pomorskie
klinika Pediatrii, Endokrynologii i Diabetologii Dziecięcej
Rzeszów
Sonomed - Centrum Medyczne
Szczecin
Klinika Endokrynologii i Diabetologii, Instytut "Pomnik Centrum Zdrowia Dziecka
Warsaw
SP Dziecięcy Szpital Kliniczny w Warszawie
Warsaw
Klinika Endokrynologii i Diabetologii Wieku Rozwojowego UM
Wroclaw
Australia4 sites
Department of Pediatrics and Endocrinology- Monash Health
Clayton, Victoria, 3168
Canberra Hospital
Garran, Australian Capital Territory, 2605
Royal Children's Hospital
Melbourne, Victoria, 3052
Queensland Children's Hospital
South Brisbane
New Zealand2 sites
Liggins Institute, University of Auckland
Auckland
Wellington Regional Hospital CCDHB
Newtown, Wellington Region, 6021
Israel1 site
Schneider Children's Medical Center Institute for Endocrinology and Diabetes National Center
Petah Tikva, Tiqwa, 4920235
Ukraine1 site
State Institution 'V. P. Komissarenko Institute of Endocrinology and Metabolism of the National academy of medical science of Ukraine
Kyiv, 04114
About this study
Official title: A Multicenter, 24-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Idiopathic Growth Hormone Deficiency (GHD)
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201.
Read the detailed description
This trial will have one screening visit with tests to assess if subjects are eligible to start study therapy. Once subjects have completed screening, and if they are determined to be eligible, they will be randomized to receive one of three oral daily doses of LUM-201 or daily injections of recombinant human growth hormone (rhGH). All subjects will have an equal chance of being placed in any of the four groups.
The trial consists of up to 24 months of treatment. After screening, subjects will return to the clinic for 6 (subjects placed in rhGH group) or 10 visits (subjects placed in LUM-201 group). During several of these clinic visits, subjects will have a physical exam, blood, and urine collections. There will also be 3 phone calls with study staff that will take place between the clinic visits.
- Conditions
- Growth Hormone Deficiency
- Being tested
- LUM-201, rhGH Norditropin® pen (34 µg/kg)
- Keywords
- GHD, Pediatric Growth Hormone Deficiency, LUM-201, Growth hormone secretagogue, Height, Catch-up growth, PEM, Oral, Predictive Enrichment Marker
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUM-201Drug
Administered orally once daily
rhGH Norditropin® pen (34 µg/kg)Drug
Administered subcutaneously (s.c., under the skin) once daily.
| Study group | Role | What they receive |
|---|---|---|
| LUM-201 (0.8 mg/kg/day) | Experimental | Not described Receives: Drug: LUM-201 |
| LUM-201 (1.6 mg/kg/day) | Experimental | Not described Receives: Drug: LUM-201 |
| LUM-201 (3.2 mg/kg/day) | Experimental | Not described Receives: Drug: LUM-201 |
| rhGH (34 µg/kg/day) | Active comparator | Not described Receives: Drug: rhGH Norditropin® pen (34 µg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Positive Growth Response From Day 1 to Month 6 (AHV >= 6.85 cm/yr)
Annualized height velocity (AHV); Height is measured in triplicate, by a calibrated stadiometer and taking the mean value AVH equation is (h2-h1/t2-t1)*365.25; h1 = height measured at day 1 h2 = height measured at month 6 t1 = day 1 t2 = month 6
Measured: Day 1 to Month 6
AHV After 6 Months on LUM-201 Compared to rhGH
Annualized height velocity to be measured.
Measured: Day 1 to Month 6
Secondary outcomes (18)
Percentage of Participants With a Positive Result on Both PEM Tests (at Screening and on Day 1)
PEM Test Reproducibility Safety Population
Measured: Screening to Day 1
Change in Height Standard Deviation Score (SDS)
Full Analysis Set Population month 6
Measured: Day 1 to Month 6
Change in Height Standard Deviation Score (SDS)
Full Analysis Set Population month 12
Measured: Day 1 to Month 12
Change in Weight From Baseline
Change in Weight from baseline
Measured: Day 1 to Month 6
Change in Weight From Baseline
Change in Weight from baseline
Measured: Day 1 to Month 12
Change in Weight SDS
Change in Weight-SDS (Standard Deviation Score)
Measured: Day 1 to Month 6
Change in Weight SDS
Change in Weight-SDS (Standard Deviation Score)
Measured: Day 1 to Month 12
Change in Body Mass Index (BMI)
Change in BMI from baseline
Measured: Day 1 to Month 6
Change in BMI
Change in BMI (Body Mass Index) from baseline
Measured: Day 1 to Month 12
Change in BMI SDS
Change in BMI SDS
Measured: Day 1 to Month 6
Change in BMI SDS
Change in BMI SDS This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Measured: Day 1 to Month 12
Bone Age
Change in bone age, measured by X-ray of left hand and wrist using Greulich \& Pyle atlas
Measured: Day 1 to Month 6
Bone Age
Change in bone age, measured by X-ray of left hand and wrist using Greulich \& Pyle atlas
Measured: Day 1 to Month 18
Pharmacokinetics of LUM-201
Serum concentrations at 30 minutes (Cmax/Steady State)
Measured: Day 1 to Month 6
Growth Hormone (GH) Concentration on Maintenance Treatment
Serum GH concentration
Measured: Month 6
Growth Hormone (GH) Concentration on Maintenance Treatment
Serum GH concentration
Measured: Month 12
Insulin-like Growth Factor 1 SDS
Serum concentrations of insulin-like growth factor 1 This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Measured: Month 6
Insulin-like Growth Factor 1 SDS
Serum concentrations of insulin-like growth factor 1 This is not a Z-Score analysis. Standard deviation score of 0 is the population mean for the age/sex. Normal range is typically -2 to +2 SDS. A positive score is an improvement and a negative score a decrease.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start31 Dec 2020
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614337
- Sponsor's protocol ID
- LUM-201-01
- Acronym
- OraGrowtH210
- Status last verified
- May 2026
- First submitted
- 26 Oct 2020
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, 24-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Idiopathic Growth Hormone Deficiency (GHD)
- ClinicalTrials.gov ID
- NCT04614337
- Acronym / sponsor ID
- OraGrowtH210 / LUM-201-01
- Conditions
- Growth Hormone Deficiency
- Keywords
- GHD, Pediatric Growth Hormone Deficiency, LUM-201, Growth hormone secretagogue, Height, Catch-up growth, PEM, Oral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Lumos PharmaIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Posted 17 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201.
Detailed description
This trial will have one screening visit with tests to assess if subjects are eligible to start study therapy. Once subjects have completed screening, and if they are determined to be eligible, they will be randomized to receive one of three oral daily doses of LUM-201 or daily injections of recombinant human growth hormone (rhGH). All subjects will have an equal chance of being placed in any of the four groups.
The trial consists of up to 24 months of treatment. After screening, subjects will return to the clinic for 6 (subjects placed in rhGH group) or 10 visits (subjects placed in LUM-201 group). During several of these clinic visits, subjects will have a physical exam, blood, and urine collections. There will also be 3 phone calls with study staff that will take place between the clinic visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LUM-201 (0.8 mg/kg/day) | Experimental | Drug: LUM-201 |
| LUM-201 (1.6 mg/kg/day) | Experimental | Drug: LUM-201 |
| LUM-201 (3.2 mg/kg/day) | Experimental | Drug: LUM-201 |
| rhGH (34 µg/kg/day) | Active comparator | Drug: rhGH Norditropin® pen (34 µg/kg) |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Have an established diagnosis of idiopathic PGHD as determined by standard diagnostic criteria. Eligible subjects must be naïve-to-treatment and be prepubertal.
- Morning cortisol ≥ 7 µg/dL or stimulated cortisol ≥ 14 µg/dL.
- At Screening, be ≥ 3.0 years and ≤ 11.0 years for girls and ≤ 12.0 years for boys.
- Have HT-SDS ≤ -2.0 or HT-SDS ≥ 2 SD below mean parental HT-SDS.
- Have a baseline height velocity < 5.5 cm/year based on at least 6 months of growth.
Key exclusion criteria (10 listed)
- Any medical or genetic condition which, in the opinion of the Investigator or Medical Monitor (MM), can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment. (Examples: diabetes, idiopathic short stature).
- A medical or genetic condition that, in the opinion of the Investigator and/or MM, adds unwarranted risk to use of LUM-201 or rhGH.
- Use of any medication that, in the opinion of the Investigator and/or MM, can independently cause short stature or limit the response to exogenous growth factors (Example: glucocorticoids).
- Evidence or history of an intracranial mass (e.g., pituitary tumor, craniopharyngioma).
- Suspicion of absent pituitary function as evidenced by a maximal stimulated GH ≤ 3 ng/mL on two prior standard of care GH stimulation tests, or pituitary deficiencies beyond GH and thyroid function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUM-201Administered orally once daily | Drug | LUM-201 (0.8 mg/kg/day), LUM-201 (1.6 mg/kg/day), LUM-201 (3.2 mg/kg/day) |
| rhGH Norditropin® pen (34 µg/kg)Administered subcutaneously (s.c., under the skin) once daily. | Drug | rhGH (34 µg/kg/day) |
Primary outcome
Percentage of Participants With a Positive Growth Response From Day 1 to Month 6 (AHV >= 6.85 cm/yr)
Time frame: Day 1 to Month 6
Annualized height velocity (AHV); Height is measured in triplicate, by a calibrated stadiometer and taking the mean value AVH equation is (h2-h1/t2-t1)*365.25; h1 = height measured at day 1 h2 = height measured at month 6 t1 = day 1 t2 = month 6
AHV After 6 Months on LUM-201 Compared to rhGH
Time frame: Day 1 to Month 6
Annualized height velocity to be measured.
18 secondary outcomes
Percentage of Participants With a Positive Result on Both PEM Tests (at Screening and on Day 1)
Time frame: Screening to Day 1
Change in Height Standard Deviation Score (SDS)
Time frame: Day 1 to Month 6
Change in Height Standard Deviation Score (SDS)
Time frame: Day 1 to Month 12
Change in Weight From Baseline
Time frame: Day 1 to Month 6
Change in Weight From Baseline
Time frame: Day 1 to Month 12
Change in Weight SDS
Time frame: Day 1 to Month 6
Change in Weight SDS
Time frame: Day 1 to Month 12
Change in Body Mass Index (BMI)
Time frame: Day 1 to Month 6
Change in BMI
Time frame: Day 1 to Month 12
Change in BMI SDS
Time frame: Day 1 to Month 6
Change in BMI SDS
Time frame: Day 1 to Month 12
Bone Age
Time frame: Day 1 to Month 6
Bone Age
Time frame: Day 1 to Month 18
Pharmacokinetics of LUM-201
Time frame: Day 1 to Month 6
Growth Hormone (GH) Concentration on Maintenance Treatment
Time frame: Month 6
Growth Hormone (GH) Concentration on Maintenance Treatment
Time frame: Month 12
Insulin-like Growth Factor 1 SDS
Time frame: Month 6
Insulin-like Growth Factor 1 SDS
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LUM-201 and rhGH Norditropin® pen (34 µg/kg) in people with Growth Hormone Deficiency, run by Lumos Pharma at 43 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Poland, Australia, New Zealand, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Positive Growth Response From Day 1 to Month 6 (AHV >= 6.85 cm/yr) (time frame: Day 1 to Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.