Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency

Conditions

• Growth Hormone Deficiency (GHD)

Eligibility Criteria

Sex

ALL

Age

3 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

• LUM-201 — DRUG
  1.6 mg/kg/day, administered orally once daily
• Matched Placebo (Capsules) — OTHER
  Administered orally once daily

Study Details

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.

Key Dates

Start date

May 20, 2026

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LUM-201
• Placebo Comparator: Placebo

Primary Outcome Measure

AHV after 12 months on LUM-201 compared to placebo [ Time Frame: Day 1 to Month 12 ]

Central Contacts

• Lumos Pharma
  515-598-2921
  [email protected]

Locations (26)

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