Efficacy, Safety, Tolerability, and Biomarker Effects of GT-02287 in Early Parkinson's Disease

Sponsor
Gain Therapeutics, Inc.
Study ID
NCT07280299
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Low Dose GT-02287 — DRUG
    Sachets containing 400 mg/day or 600 mg/day of active (GT-02287), depending on the participant's body weight. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water.
  • High Dose GT-02287 — DRUG
    Sachets containing 800 mg/day or 1000 mg/day of active (GT-02287), depending on the participant's body weight. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water.
  • Placebo — DRUG
    Sachets containing 420 to 1200 mg of MAS indistinguishable from the active sachets. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water.

Study Details

The purpose of this study is to assess the efficacy, the safety, and the effect on biomarkers of 2 dose levels of oral GT-02287 over placebo after 48 weeks of treatment in treated and untreated participants with early PD.

Key Dates

First listed
Dec 12, 2025
Start date
May 30, 2026
Status verified
Nov 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
111 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Low Dose GT-02287
    GT-02287 400 or 600 mg/day
  • Active Comparator: High Dose GT-02287
    GT-02287 800 or 1000 mg/day
  • Placebo Comparator: Placebo
    Magnesium aluminometasilicate (MAS)

Primary Outcome Measure

Change from Baseline to Week 48 in the sum of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and Part III score [Efficacy] [ Time Frame: From baseline to Week 48 ]

Central Contacts

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