Trial of Lixisenatide in Early Parkinson's Disease
- Design
- Randomized trial · 156 participants · Intermediate outcome
- Match to healthy normal-weight adults aged 55–75
- Partial matchNot selected for obesity or diabetes; early PD patients. Outcome is disease-specific.
- Could weight loss explain it?
- UnlikelyMotor progression endpoint; weight loss not a plausible mediator, but nausea (46%) may have affected blinding.
- Study tier
- Study tier 3Small phase 2 trial with a modest, on-medication difference; secondary endpoints mostly null; larger phase 3 with a different agent was negative.
- Assessment
- Version 2 · curated · Sep 13, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
In 156 people with early Parkinson's disease, daily lixisenatide was associated with about 3 points less motor worsening over 12 months, at the cost of frequent nausea. This is a small phase 2 signal that a larger, longer exenatide trial did not support.
01Findings
What the study reported
- Drugs
- Lixisenatide
- Dose
- daily (10 then 20 micrograms, full text)
- Route
- subcutaneous
- Treatment duration
- 12 months plus 2-month washout
- Comparator
- placebo
- Primary outcome
- Change in MDS-UPDRS part III on-medication at 12 months
- Effect
- Difference 3.08 points favouring lixisenatide (-0.04 vs +3.04)
- 95% confidence interval
- 0.86 to 5.30
- P value
- 0.007
- Follow-up
- 12 months (+2 months washout)
- Adverse events
- Nausea 46%, vomiting 13%.
- Limitations
- Auto-classified from abstract only; effect estimates, adverse events and limitations not extracted. Requires manual review.
Who was studied
- Obesity status
- not an entry criterion
- Diabetes status
- not an entry criterion (diabetes excluded per protocol, full text)
- Baseline condition
- early Parkinson's disease (<3 years), no motor complications
- Sample size
- 156
Study quality details
- Study design
- Randomized controlled trial
- Sample size
- 156
- Randomization
- yes
- Blinding
- double-blind (possible unblinding by GI effects)
- Comparator
- placebo
- Follow up duration
- 3 years
- Outcome type
- mixed
- Replication
- not replicated; contradicted by larger exenatide phase 3
- Consistency with other evidence
- not assessed (auto)
- Population applicability
- PARTIAL
- Statistical precision
- small; CI lower bound near zero
- Risk of bias
- not assessed (auto)
- Funding conflicts
- no
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- French Ministry of Health and others; Cure Parkinson's (full text)
- Industry funded
- No
- Manufacturer
- None identified
- Sponsor role
- Academic sponsor; Sanofi supplied drug (full text).
- Author conflicts
- See published disclosures.
- Independent replication
- no
Funding is shown on every study and never used to score it.
03Claims
Claims this study bears on
- GLP-1 receptor agonists slow progression of Parkinson's disease.Supports
LixiPark phase 2 (n=156): 3.08-point difference on MDS-UPDRS III at 12 months; 46% nausea.
04Source
The source, as retrieved
Abstract
[BACKGROUND] Lixisenatide, a glucagon-like peptide-1 receptor agonist used for the treatment of diabetes, has shown neuroprotective properties in a mouse model of Parkinson's disease. [METHODS] In this phase 2, double-blind, randomized, placebo-controlled trial, we assessed the effect of lixisenatide on the progression of motor disability in persons with Parkinson's disease. Participants in whom Parkinson's disease was diagnosed less than 3 years earlier, who were receiving a stable dose of medications to treat symptoms, and who did not have motor complications were randomly assigned in a 1:1 ratio to daily subcutaneous lixisenatide or placebo for 12 months, followed by a 2-month washout period. The primary end point was the change from baseline in scores on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (range, 0 to 132, with higher scores indicating greater motor disability), which was assessed in patients in the on-medication state at 12 months. Secondary end points included other MDS-UPDRS subscores at 6, 12, and 14 months and doses of levodopa equivalent. [RESULTS] A total of 156 persons were enrolled, with 78 assigned to each group. MDS-UPDRS part III scores at baseline were approximately 15 in both groups. At 12 months, scores on the MDS-UPDRS part III had changed by -0.04 points (indicating improvement) in the lixisenatide group and 3.04 points (indicating worsening disability) in the placebo group (difference, 3.08; 95% confidence interval, 0.86 to 5.30; P = 0.007). At 14 months, after a 2-month washout period, the mean MDS-UPDRS motor scores in the off-medication state were 17.7 (95% CI, 15.7 to 19.7) with lixisenatide and 20.6 (95% CI, 18.5 to 22.8) with placebo. Other results relative to the secondary end points did not differ substantially between the groups. Nausea occurred in 46% of participants receiving lixisenatide, and vomiting occurred in 13%. [CONCLUSIONS] 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. Longer and larger trials are needed to determine the effects and safety of lixisenatide in persons with Parkinson's disease. (Funded by the French Ministry of Health and others; LIXIPARK ClinicalTrials.gov number, NCT03439943.).
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Sep 13, 2026 | 38598572 first ingestion |