Centennial, CONCT06948214Now EnrollingIRB Ready

Growth Hormone Deficiency (GHD) Clinical Trial in Centennial, CO

Access cutting-edge growth hormone deficiency (ghd) treatment through this clinical trial at a research site in Centennial. Study-provided care at no cost to qualified participants.

Sponsored by Lumos Pharma

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Expert Care in Centennial

Access growth hormone deficiency (ghd) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related growth hormone deficiency (ghd) treatment provided free

Apply for This Centennial Location

Check if you qualify for this growth hormone deficiency (ghd) clinical trial in Centennial, CO

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Centennial

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Centennial site if eligible
  4. 4Begin participation

About This Growth Hormone Deficiency (GHD) Study in Centennial

The OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive enrichment marker (LUM-201 PEM) strategy to select subjects likely to respond to therapy with daily oral LUM-201.

Sponsor: Lumos Pharma

Who Can Participate

Inclusion Criteria

Subjects must be naïve to treatment and prepubertal
Subjects must have a maximal GH response of \< 10 ng/mL from 2 prior GH stimulation tests conducted within the preceding 12 months
Impaired height defined as ≥ 2.0 standard deviations (SDs) below the mean height for chronological age and sex
Morning or random cortisol level of ≥ 7.0 μg/dL
≥ 3.0 years and age ≤ 10.0 years for girls and ≤ 11.0 years for boys
Baseline height velocity (HV) based on ≥ 6 months of growth assessments \< 25th percentile for age and sex
Bone Age delay of ≥ 12 months compared to the chronological age
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 3 months prior to Day 1
Baseline IGF-1 standard deviation score (SDS) ≤ -1.0

Exclusion Criteria

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.
Arm span to height ratio \> 2 SDs below the mean for age and sex
A medical or genetic condition that, in the opinion of the Investigator and/or MM, adds unwarranted risk to use of LUM-201
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
Current inflammatory diseases requiring systemic corticosteroid treatment for \> 2 consecutive weeks within the last 3 months prior to the Screening Visit
Use of hormone replacement therapy for any hormone deficiency other than thyroid deficiency
Any ECG at the Screening Visit noted to have a clinically significant abnormality, as confirmed by the MM
Any subjects suspected of having past or present intracranial tumor growth as confirmed by brain imaging prior to the Screening or Day 1 Visit
Any subject suspected of having intracranial hypertension (IH) as confirmed by fundoscopy and other assessments
Any subject with serum alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin \> upper limit of normal (ULN)
Suspicion of absent pituitary function as evidenced by a maximal stimulated GH ≤ 3.0 ng/mL on any prior standard of care GH stimulation test completed within 12 months
Body weight ≤ 14.0 kg
BMI \< -2 or \> +2 SDs for age and sex based on WHO standards
Birth weight for gestational age \< 3rd percentile based on WHO standards
Treatment with medications known to be moderate or strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A/4
History of spinal, cranial, or total body irradiation
Attention deficit hyperactivity disorder (ADHD) diagnosis

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Centennial?

Yes, this clinical trial (NCT06948214) has an active research site in Centennial, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Growth Hormone Deficiency (GHD) Treatment Options in Centennial, CO

If you're searching for growth hormone deficiency (ghd) treatment options in Centennial, CO, this clinical trial (NCT06948214) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Centennial research site is actively enrolling participants for this clinical trial. You'll receive care from experienced growth hormone deficiency (ghd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all growth hormone deficiency (ghd) clinical trials near you to find additional studies recruiting in your area.

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