Phase 2
Completed N=63
Safety and Efficacy of Liraglutide in Parkinson's Disease
Source: ClinicalTrials.gov NCT02953665 ↗Enrolled (actual)
63
Serious AEs
17.5%
Results posted
Mar 2024
Primary outcomePrimary: Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During "OFF" Time From Baseline to the End of Double-Blind Maintenance Period — -2.3; -5.0 units on a scale
Summary
The purpose of this study is to test the efficacy and safety of liraglutide in the treatment of patients with idiopathic Parkinson's disease (PD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During "OFF" Time From Baseline to the End of Double-Blind Maintenance Period |
-2.3; -5.0 | — |
| PRIMARY Change in the Non-Motor Symptoms Scale (NMSS) Total Score From Baseline to the End of the Double-Blind Maintenance Period |
-5.5; 6.5 | — |
| PRIMARY Change in the Mattis Dementia Rating Scale (DRS-2) From Baseline to the End of Double-Blind Maintenance Period |
1.4; -0.3 | — |
| SECONDARY Change in the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index From Baseline to the End of Maintenance Period |
0.1; 0.3 | — |
| SECONDARY Change in the Unified Parkinson's Disease Rating Scale Total Score From Baseline to the End of Double-Blind Maintenance Period |
-4.9; 2.3 | — |
| SECONDARY Change in The Parkinson's Disease Questionnaire (PDQ-39) From Baseline to the End of Double-Blind Maintenance Period |
-2.5; 11.2 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria for at least 2 years
- Responsive to levodopa or dopaminergic treatment
- Male or female between 25 and 85 years of age at time of enrollment
- Women of child-bearing potential (WOCBP) must agree to use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double barrier methods (such as condom plus diaphragm, condom plus spermicide foam, condom plus sponge), or intra-uterine devices) throughout the duration of the trial period and must have a negative serum pregnancy test at screening
- Male patients with female partners who have child bearing potential must agree to use adequate contraception throughout the duration of the trial period
- Capacity to give informed consent
- Ability to self-administer, or to arrange a care partner to administer trial drug, to comply with trial protocol, and to attend necessary clinic visits off medication
Exclusion Criteria
- Diagnosis or suspicion of other causes for Parkinsonism, including drug- or toxin-induced parkinsonism and other neurodegenerative conditions, including multiple system atrophy, progressive supranuclear palsy, Huntington's disease, Wilson's disease, or Alzheimer's disease
- Active treatment with anticholinergic medications (e.g., trihexyphenidyl, tricyclic antidepressants)
- Known abnormality on CT or MRI brain imaging considered to cause symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with trial protocol
- Concurrent dementia defined by a score lower than 120 on the MADRS-2 and/or inability to complete scale per neuropsychologist discretion
- Concurrent severe depression defined by a score greater than 29 on the Beck Depression Inventory
- Prior intracerebral surgical intervention for PD, including deep brain stimulation, lesional surgery, growth factor administration, gene therapy, or cell transplant
- Already actively participating in a trial of a device, drug, or surgical treatment for PD, or trial participation within 30 days prior to the baseline visit
- Diagnosis of diabetes mellitus of any type, established historically or by:
- Fasting plasma glucose levels equal or above 126 mg/dl
- Hemoglobin A1c equal or above 6.5%
- Active treatment with oral antidiabetic medications
- History of severe cardiac disease (e.g., angina, myocardial infarction, or cardiac surgery) in the preceding year
- Significant systemic illness likely to result in deterioration of the patient's condition or, in the Investigator's opinion, affect the patient's safety during the study, including in particular:
- History of pancreatitis
- Personal or family history of medullary thyroid carcinoma
- History of multiple endocrine neoplasia syndrome type 2
- History of alcoholism
- Severe gastrointestinal disease, including gastroparesis
- Treatment with immunosuppressive medications (e.g., systemic corticosteroids) within the last 90 days or chemotherapeutic agents for malignancy within the last 2 years
- Severe renal insufficiency (CrCl 500 mg/dl)
- Females who are pregnant or breast feeding
- Prior serious hypersensitivity reaction to Victoza or any of the product components 10) Body Mass Index <18.5
Data sourced from ClinicalTrials.gov (NCT02953665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.