Phase 2 · Liraglutide

NCT02953665 trial results

A Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's Disease

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 (units on a scale), From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks). Full Analysis Set (Liraglutide-treated Subjects): -2.3; Full Analysis Set (Placebo-treated Subjects): -5.0.

Participants
63
Status
completed
Completed
2022-08-03
Sponsor
Cedars-Sinai Medical Center

As posted on ClinicalTrials.gov (NCT02953665), updated at source Mar 7, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02953665 measured first

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 Periodunits on a scale · From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks) · mean
Full Analysis Set (Liraglutide-treated Subjects)n=33Full Analysis Set (Placebo-treated Subjects)n=18
-2.3(9.4)-5.0(7.1)
Change in the Non-Motor Symptoms Scale (NMSS) Total Score From Baseline to the End of the Double-Blind Maintenance Periodunits on a scale · From Baseline (Week 0) to the End of Maintenance Period (up to Week 54) · mean
Full Analysis Set (Liraglutide-treated Subjects)n=33Full Analysis Set (Placebo-treated Subjects)n=18
-5.5(25.3)6.5(21.3)
Change in the Mattis Dementia Rating Scale (DRS-2) From Baseline to the End of Double-Blind Maintenance Periodunits on a scale · From Baseline (Week 0) to the end of Maintenance Period (up to 54 weeks) · mean
Full Analysis Set (Liraglutide-treated Subjects)n=33Full Analysis Set (Placebo-treated Subjects)n=18
1.4(9.3)-0.3(9.1)
Side effects by arm

Side effects in NCT02953665

Percent of participants affected, Adverse Event collection commenced upon signing of consent at Screening and occurred at Baseline Week 1, Week 2, Week 6, Week 14, Week 28, Week 38, Week 54, and at follow-up Week 58.. The most common events the registry lists.

EventLiraglutidePlacebo
Any serious event21.4%9.5%
Loss of Appetite61.9%0%
Nausea57.1%14.3%
Dyspepsia28.6%14.3%
Injection Site Reaction23.8%14.3%
Other Pain16.7%4.8%
Back Pain11.9%14.3%
Diarrhea14.3%9.5%
Upper Respiratory Tract Infection9.5%14.3%
Constipation14.3%0%
Vomiting11.9%0%
Fatigue9.5%4.8%
Headache7.1%9.5%
Sleep Disorder9.5%4.8%
Urinary Tract Infection7.1%9.5%
Worsening Off Time7.1%9.5%
Secondary outcomes

What else it measured

Change in the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index From Baseline to the End of Maintenance Periodunits on a scale · From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks) · mean
Full Analysis Set (Liraglutide-treated Subjects)n=33Full Analysis Set (Placebo-treated Subjects)n=18
0.1(1.1)0.3(0.8)
Change in the Unified Parkinson's Disease Rating Scale Total Score From Baseline to the End of Double-Blind Maintenance Periodunits on a scale · From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks) · mean
Full Analysis Set (Liraglutide-treated Subjects)n=33Full Analysis Set (Placebo-treated Subjects)n=18
-4.9(12.7)2.3(10.4)
Change in The Parkinson's Disease Questionnaire (PDQ-39) From Baseline to the End of Double-Blind Maintenance Periodunits on a scale · From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks) · mean
Full Analysis Set (Liraglutide-treated Subjects)n=33Full Analysis Set (Placebo-treated Subjects)n=18
-2.5(9.9)11.2(14.0)
The trial

How NCT02953665 was run

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).

  • Liraglutide: Liraglutide 6 mg/ml (Novo Nordisk A/S) will be self-administered subcutaneously once daily at a maximum dose of 1.8 mg after a 2 week titration schedule.
  • Placebo: Placebo will be self-administered subcutaneously once daily according to the same schedule.
Who could join the trial

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: 1. History of pancreatitis 2. Personal or family history of medullary thyroid carcinoma 3. History of multiple endocrine neoplasia syndrome type 2 4. History of alcoholism 5. Severe gastrointestinal disease, including gastroparesis 6....

Published papers

Papers from NCT02953665

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.