GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT02953665

CompletedPhase 2Results posted

Safety and Efficacy of Liraglutide in Parkinson's Disease

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

Lead sponsor

Cedars-Sinai Medical Center

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Parkinson's disease

Key I/E criterion

—

Primary endpoints

•Unified Parkinson's Disease Rating Scale During "OFF" Time From Baseline to•The Non-Motor Symptoms Scale (NMSS) Total Score From Baseline to the End of•The Mattis Dementia Rating Scale (DRS-2) From Baseline to the End

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02953665

Org study IDU1111-1173-0106

Timeline

Milestones

Study first posted2016-11-03estimated

Study start2017-04-03actual

Primary completion2022-08-03actual

Study completion2022-08-03actual

Last update posted2024-03-07actual

Results first posted2024-03-07actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Parkinson's disease

Eligibility

Who can enroll

Minimum age25 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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. Treatment with immunosuppressive medications (e.g., systemic corticosteroids) within the last 90 days or chemotherapeutic agents for malignancy within the last 2 years

7. Severe renal insufficiency (CrCl <30)

8. Moderate or severe hepatic impairment

9. Severe hypertriglyceridemia (triglycerides >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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Patient-reported / QoL

Glycemic / diabetes

2 endpoints

Secondary/registry result

Change in the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index From Baseline to the End of Maintenance Period

Time frame:From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Full Analysis Set (Liraglutide-treated Subjects)	0.1	—
Full Analysis Set (Placebo-treated Subjects)	0.3	—

Secondary/protocol endpoint

Change in the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index From Baseline to the End of Maintenance Period

Time frame:From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Primary/registry result

Change in the Non-Motor Symptoms Scale (NMSS) Total Score From Baseline to the End of the Double-Blind Maintenance Period

Time frame:From Baseline (Week 0) to the End of Maintenance Period (up to Week 54)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Full Analysis Set (Liraglutide-treated Subjects)	-5.5	—
Full Analysis Set (Placebo-treated Subjects)	6.5	—

Primary/protocol endpoint

Change in the Non-Motor Symptoms Scale (NMSS) Total Score From Baseline to the End of the Double-Blind Maintenance Period

Time frame:From Baseline (Week 0) to the End of Maintenance Period (up to Week 54)

change from baseline, improvement

Secondary/registry result

Change in The Parkinson's Disease Questionnaire (PDQ-39) From Baseline to the End of Double-Blind Maintenance Period

Time frame:From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Full Analysis Set (Liraglutide-treated Subjects)	-2.5	—
Full Analysis Set (Placebo-treated Subjects)	11.2	—

Secondary/protocol endpoint

Change in The Parkinson's Disease Questionnaire (PDQ-39) From Baseline to the End of Double-Blind Maintenance Period

Time frame:From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)

change from baseline, improvement

Other clinical outcomes

6 endpoints

Primary/registry result

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

Time frame:From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Full Analysis Set (Liraglutide-treated Subjects)	-2.3	—
Full Analysis Set (Placebo-treated Subjects)	-5.0	—

Primary/registry result/low confidence

Change in the Mattis Dementia Rating Scale (DRS-2) From Baseline to the End of Double-Blind Maintenance Period

Time frame:From Baseline (Week 0) to the end of Maintenance Period (up to 54 weeks)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Full Analysis Set (Liraglutide-treated Subjects)	1.4	—
Full Analysis Set (Placebo-treated Subjects)	-0.3	—

Primary/protocol endpoint

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

Time frame:From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)

change from baseline, improvement

Primary/protocol endpoint

Change in the Mattis Dementia Rating Scale (DRS-2) From Baseline to the End of Double-Blind Maintenance Period

Time frame:From Baseline (Week 0) to the end of Maintenance Period (up to 54 weeks)

change from baseline, improvement

Secondary/registry result/low confidence

Change in the Unified Parkinson's Disease Rating Scale Total Score From Baseline to the End of Double-Blind Maintenance Period

Time frame:From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Full Analysis Set (Liraglutide-treated Subjects)	-4.9	—
Full Analysis Set (Placebo-treated Subjects)	2.3	—

Secondary/protocol endpoint

Change in the Unified Parkinson's Disease Rating Scale Total Score From Baseline to the End of Double-Blind Maintenance Period

Time frame:From Baseline (Week 0) to end of Maintenance Period (up to 54 weeks)

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

The Novel Dual GLP-1/GIP Receptor Agonist DA-CH5 Is Superior to Single GLP-1 Receptor Agonists in the MPTP Model of Parkinson's Disease.
Journal of Parkinson's disease2020 (year)PMID31958096doi:10.3233/JPD-191768via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.