LIXIPARK Trial: Lixisenatide in Early Parkinson’s Disease

lixipark trial
  • Year: 2024
  • Subtitle: Trial of Lixisenatide in Early Parkinson’s Disease
  • Trial Type: A phase 2, double-blind, randomized, placebo-controlled trial

Objective: To evaluate the effect of lixisenatide, versus placebo, administered as add-on therapy with the usual antiparkinsonian treatment, on the progression of motor disability in patients with early Parkinson’s Disease (PD) to assess its potential “disease-modifying” effect.

Inclusion Criteria:

  • Age 40 to 75 years
  • Parkinson’s disease diagnosed less than 3 years earlier
  • Receiving a stable dose of medications to treat symptoms
  • Have no motor complications

Exclusion Criteria:

  • Parkinsonian syndromes
  • BMI < 18.5
  • Type 1 or type 2 diabetic
  • Severe depression or cognitive impairment

Participants: 156 Patients

Treatment Groups:

  • Lixisenatide (Daily subcutaneous) – 78 patients
  • Placebo – 78 patients

Primary Outcome:

  • Change in MDS-UPDRS part III score from baseline (Points)
  • Difference: 3.08; 95% CI, 0.86 to 5.30 (P=0.007)

Secondary Outcomes:

  • Adverse events % Nausea: Lixisenatide 46%, Placebo 12%
  • Adverse events % Vomiting: Lixisenatide 13%, Placebo 3%

Conclusion: In participants with early Parkinson’s disease, lixisenatide therapy resulted in less progression of motor disability than placebo at 12 months in a phase 2 trial but was associated with gastrointestinal side effects.

Reference: Meissner WG et al. N Engl J Med 2024;390:1176-1185

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