Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUM-201 (0.8 mg/kg/day) | Experimental |
| |
| LUM-201 (1.6 mg/kg/day) | Experimental |
| |
| LUM-201 (3.2 mg/kg/day) | Experimental |
| |
| rhGH (34 µg/kg/day) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUM-201 | Drug | Administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 to Month 6 |
| AHV After 6 Months on LUM-201 Compared to rhGH | Annualized height velocity to be measured. | Day 1 to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Positive Result on Both PEM Tests (at Screening and on Day 1) | PEM Test Reproducibility Safety Population | Screening to Day 1 |
| Change in Height Standard Deviation Score (SDS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Excellence in Diabetes and Endocrinology | Sacramento | California | 95821 | United States | ||
| Rady Children's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Predictive Enrichment Marker (PEM) Dose LUM-201 (0.8 mg/kg/Day) | LUM-201: Administered orally once |
| FG001 | LUM-201 (0.8 mg/kg/Day) | LUM-201: Administered orally once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Qualification Phase |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2022 | Feb 5, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| rhGH Norditropin® pen (34 µg/kg) | Drug | Administered subcutaneously (s.c., under the skin) once daily. |
|
Full Analysis Set Population month 6
| Day 1 to Month 6 |
| Change in Height Standard Deviation Score (SDS) | Full Analysis Set Population month 12 | Day 1 to Month 12 |
| Change in Weight From Baseline | Change in Weight from baseline | Day 1 to Month 6 |
| Change in Weight From Baseline | Change in Weight from baseline | Day 1 to Month 12 |
| Change in Weight SDS | Change in Weight-SDS (Standard Deviation Score) | Day 1 to Month 6 |
| Change in Weight SDS | Change in Weight-SDS (Standard Deviation Score) | Day 1 to Month 12 |
| Change in Body Mass Index (BMI) | Change in BMI from baseline | Day 1 to Month 6 |
| Change in BMI | Change in BMI (Body Mass Index) from baseline | Day 1 to Month 12 |
| Change in BMI SDS | Change in BMI SDS | 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. | Day 1 to Month 12 |
| Bone Age | Change in bone age, measured by X-ray of left hand and wrist using Greulich & Pyle atlas | Day 1 to Month 6 |
| Bone Age | Change in bone age, measured by X-ray of left hand and wrist using Greulich & Pyle atlas | Day 1 to Month 18 |
| Pharmacokinetics of LUM-201 | Serum concentrations at 30 minutes (Cmax/Steady State) | Day 1 to Month 6 |
| Growth Hormone (GH) Concentration on Maintenance Treatment | Serum GH concentration | Month 6 |
| Growth Hormone (GH) Concentration on Maintenance Treatment | Serum GH concentration | 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. | 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. | Month 12 |
| San Diego |
| California |
| 92123 |
| United States |
| Pediatric Endocrine Associates | Greenwood Village | Colorado | 80111 | United States |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Novak Center For Childrens Health | Louisville | Kentucky | 40202 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| M Health, Fairview Pediatric Specialty Clinics- Discovery Clinic | Minneapolis | Minnesota | 55454 | United States |
| Children's Minnesota | Saint Paul | Minnesota | 55102 | United States |
| The Children's Mercy Hospital | Kansas City | Missouri | 64111 | United States |
| UBMD Pediatrics | Buffalo | New York | 14203 | United States |
| The Mount Sinai Hospital | Mount Sinai | New York | 30093 | United States |
| NYU Grossman School of Medicine | New York | New York | 10016 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| University of Oklahoma Health Sciences Center, Pediatric Diabetes and Endocrinology | Oklahoma City | Oklahoma | 73104 | United States |
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Tech University Health Sciences Center | Amarillo | Texas | 79106 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Diabetes & Glandular Disease Clinic, P.A. | San Antonio | Texas | 78229 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia |
| Department of Pediatrics and Endocrinology- Monash Health | Clayton | Victoria | 3168 | Australia |
| Royal Children's Hospital | Melbourne | Victoria | 3052 | Australia |
| Queensland Children's Hospital | South Brisbane | Australia |
| Schneider Children's Medical Center Institute for Endocrinology and Diabetes National Center | Petah Tikva | Tiqwa | 4920235 | Israel |
| Wellington Regional Hospital CCDHB | Newtown | Wellington Region | 6021 | New Zealand |
| Liggins Institute, University of Auckland | Auckland | New Zealand |
| Klinika Pediatrii, Endokrynologii, Diabetologii z Pododdziałem Kardiologii, Uniwersytecki Dziecięcy Szpital Kliniczny im.Ludwika Zamenhofa w Białymstoku | Bialystok | Poland |
| Klinika Endokrynologii i Chorob Metabolicznych, Instytut Centrum Zdrowia Matki Polki | Lodz | Poland |
| Klinika Pediatrii, Diabetologii i Endokrynologii Gdansk | Pomorskie | Poland |
| klinika Pediatrii, Endokrynologii i Diabetologii Dziecięcej | Rzeszów | Poland |
| Sonomed - Centrum Medyczne | Szczecin | Poland |
| Klinika Endokrynologii i Diabetologii, Instytut "Pomnik Centrum Zdrowia Dziecka | Warsaw | Poland |
| SP Dziecięcy Szpital Kliniczny w Warszawie | Warsaw | Poland |
| Klinika Endokrynologii i Diabetologii Wieku Rozwojowego UM | Wroclaw | Poland |
| State Institution 'V. P. Komissarenko Institute of Endocrinology and Metabolism of the National academy of medical science of Ukraine | Kyiv | 04114 | Ukraine |
| FG002 | LUM-201 (1.6 mg/kg/Day) | LUM-201: Administered orally once daily |
| FG003 | LUM-201 (3.2 mg/kg/Day) | LUM-201: Administered orally once daily |
| FG004 | rhGH (34 µg/kg/Day) | rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2: Randomization Phase |
|
|
PEM Dose LUM-201 (0.8 mg/kg/day) was not considered a dose arm as it was a qualification that needed to be met in order for subjects to enter the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LUM-201 (0.8 mg/kg/Day) | LUM-201: Administered orally once daily |
| BG001 | LUM-201 (1.6 mg/kg/Day) | LUM-201: Administered orally once daily |
| BG002 | LUM-201 (3.2 mg/kg/Day) | LUM-201: Administered orally once daily |
| BG003 | rhGH (34 µg/kg/Day) | rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Bone Age (BA) | Measured by X-ray of left hand and wrist using Greulich & Pyle atlas | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | percentage of participants | Day 1 to Month 6 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | AHV After 6 Months on LUM-201 Compared to rhGH | Annualized height velocity to be measured. | This is the per protocol population. | Posted | Mean | Standard Deviation | centimeters per year | Day 1 to Month 6 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Positive Result on Both PEM Tests (at Screening and on Day 1) | PEM Test Reproducibility Safety Population | All subject data was combined as this test was part of study eligibility. Participants analyzed does not match participants enrolled because not all 2nd PEM results were done. | Posted | Number | 95% Confidence Interval | percentage of participants | Screening to Day 1 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in Height Standard Deviation Score (SDS) | Full Analysis Set Population month 6 | 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. | Posted | Mean | Standard Deviation | Standard Deviation Score | Day 1 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Height Standard Deviation Score (SDS) | Full Analysis Set Population month 12 | 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. | Posted | Mean | Standard Deviation | Standard Deviation Score | Day 1 to Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Weight From Baseline | Change in Weight from baseline | Posted | Mean | Standard Deviation | kg | Day 1 to Month 6 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Weight From Baseline | Change in Weight from baseline | Posted | Mean | Standard Deviation | kg | Day 1 to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Weight SDS | Change in Weight-SDS (Standard Deviation Score) | 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. | Posted | Mean | Standard Deviation | Standard Deviation Score | Day 1 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Weight SDS | Change in Weight-SDS (Standard Deviation Score) | 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. | Posted | Mean | Standard Deviation | Standard Deviation Score | Day 1 to Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Mass Index (BMI) | Change in BMI from baseline | Posted | Mean | Standard Deviation | kg/m2 | Day 1 to Month 6 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in BMI | Change in BMI (Body Mass Index) from baseline | Posted | Mean | Standard Deviation | kg/m2 | Day 1 to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | Standard Deviation Score | Day 1 to Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | Standard Deviation Score | Day 1 to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Bone Age | Change in bone age, measured by X-ray of left hand and wrist using Greulich & Pyle atlas | Posted | Mean | Standard Deviation | Years | Day 1 to Month 6 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Bone Age | Change in bone age, measured by X-ray of left hand and wrist using Greulich & Pyle atlas | rhGH was not included because that group ended at month 12 | Posted | Mean | Standard Deviation | Years | Day 1 to Month 18 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics of LUM-201 | Serum concentrations at 30 minutes (Cmax/Steady State) | Subject numbers differ at Day 1 and month 1 due to changes in PK sample collection timing that occurred as per protocol amendments throughout the trial | Posted | Mean | Standard Deviation | Concentration (ng/mL) | Day 1 to Month 6 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Growth Hormone (GH) Concentration on Maintenance Treatment | Serum GH concentration | rhGH group was not included because samples were not collected | Posted | Mean | Standard Deviation | ng/ml | Month 6 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Growth Hormone (GH) Concentration on Maintenance Treatment | Serum GH concentration | rhGH group was not included because samples were not collected | Posted | Mean | Standard Deviation | ng/ml | Month 12 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Absolute values were reported not change from baseline. | Posted | Mean | Standard Deviation | Standard Deviation Score | Month 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Absolute values were reported not change from baseline. | Posted | Mean | Standard Deviation | Standard Deviation Score | Month 12 |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEM Dose LUM-201 (0.8 mg/kg/Day) | LUM-201: Administered orally once daily | 0 | 104 | 1 | 104 | 22 | 104 |
| EG001 | LUM-201 (0.8 mg/kg/Day) | LUM-201: Administered orally once daily | 0 | 18 | 1 | 18 | 14 | 18 |
| EG002 | LUM-201 (1.6 mg/kg/Day) | LUM-201: Administered orally once daily | 0 | 22 | 1 | 22 | 21 | 22 |
| EG003 | LUM-201 (3.2 mg/kg/Day) | LUM-201: Administered orally once daily | 0 | 22 | 0 | 22 | 20 | 22 |
| EG004 | rhGH (34 µg/kg/Day) | rhGH Norditropin® pen (34 µg/kg): Administered subcutaneously (s.c., under the skin) once daily. | 0 | 20 | 1 | 20 | 17 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cartilage development disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Glycosuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Deyhdration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Ear infection | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
| ||
| Entereobiasis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infections | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Systematic Assessment |
| ||
| Varicella | Infections and infestations | Systematic Assessment |
| ||
| Gastrointestinal viral infection | Infections and infestations | Systematic Assessment |
| ||
| Giardiasis | Infections and infestations | Systematic Assessment |
| ||
| Scrotal infection | Infections and infestations | Systematic Assessment |
| ||
| Smallpox | Infections and infestations | Systematic Assessment |
| ||
| Tooth abcess | Infections and infestations | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pharyngitis streptococcal | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cartilage development disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Growing pains | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Synovitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pyrexia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Scrotal injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vaccination complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Blood urine present | Investigations | Systematic Assessment |
| ||
| Transaminases increased | Investigations | Systematic Assessment |
| ||
| Asthenopia | Eye disorders | Systematic Assessment |
| ||
| Visual impairment | Eye disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Seasonal allergy | Immune system disorders | Systematic Assessment |
| ||
| Allergy to arthropod sting | Immune system disorders | Systematic Assessment |
| ||
| Glycosuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Eye naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Injection site bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lumos Pharma LLC. | Lumos Pharma LLC | 515-598-2921 | clinical.trials@lumos-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2024 | Feb 5, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| Failed Annualized Height Velocity Criteria, or transitioned to Extension study early. |
|
| Physician Decision |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|