DelfaGLP-1 Atlas

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MSA

CompletedPhase 2Results posted

Exenatide Once-weekly as a Treatment for Multiple System Atrophy

An Open Label, Single Site, 48 Week, Randomised Controlled Trial Evaluating the Safety and Efficacy of Exenatide Once-weekly in the Treatment of Patients With Multiple System Atrophy

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

50

actual

Study population

—

Key I/E criterion

—

Primary endpoint

•UMSARS Score (Parts I+II)

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 IDNCT04431713
Org study ID125591
Secondary ID2020-000122-26

Timeline

Milestones

Study first posted2020-06-16actual
Study start2020-09-16actual
Primary completion2024-03-22actual
Study completion2024-03-22actual
Last update posted2025-06-27actual
Results first posted2025-06-27actual

Assets

Investigational agents

Exenatide

Eligibility

Who can enroll

Minimum age30 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Participants aged 30-80 years old with a diagnosis of Possible or Probable MSA of the parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (Gilman et al. 2008).
•Participants who are less than five years from the time of documented MSA diagnosis or from the time of documented parkinsonian / ataxic neurological condition that later turns out to be MSA.
•Participants who are able to walk at least 10 metres with or without assistance. Participants with an anticipated survival of at least three years in the opinion of the investigator.
•Participants that are willing to adhere to the study drug regimen.
•Participants that are willing and able to perform all protocol-specified assessments and comply with the study visit schedule.
•Females of childbearing potential and male participants with partners of childbearing potential must agree to use an effective method of contraception from the time consent is signed until 10 weeks after treatment discontinuation. Females of childbearing potential have a negative pregnancy test within 7 days prior to being randomised.
•Willing and able to provide written informed consent.
•Subjects who are not able to write may give verbal consent in the presence of at least one witness, and the witness should sign the informed consent form.

Exclusion criteria

•Females who are pregnant, planning pregnancy or breastfeeding.
•Women of child-bearing potential who do not practice an acceptable method of birth control. Subjects who meet any of the following criteria which tend to suggest advance disease:

1. Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1

2. Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2

3. Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7

4. Falling more frequently than once per week as assessed by a score of ≥ 3 on UMSARS question 8. Participants with a clinically significant or unstable medical or surgical condition, which in the opinion of the investigator might preclude safe completion of the study.

•Participants with active malignant neoplasms or history of malignant neoplasm in the last 5 years. Participants with movement disorders other than MSA.
•Concurrent dementia defined by a score lower than 21 on the MoCA.
•Concurrent severe depression defined by a score of ≥30 on the Beck Depression Inventory-II.
•History of deep brain stimulation surgery.
•Participants who have taken any investigational products within 90 days prior to baseline.
•Participants with a BMI < 18.5.
•Participants with diabetes, end stage renal disease or severely impaired renal function.
•History of clinically significant cardiac disease, pancreatitis and/or alcoholism.
•Participants with severe gastrointestinal disease including gastroparesis.
•Ongoing treatment with sulphonylurea.
•Known allergies to the IMP and excipients of IMP.

Endpoints (9)

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
6
Patient-reported / QoL
3

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint

Multiple System Atrophy Quality of Life (MSA-QoL) Scale

Time frame:48 weeks

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
ExenatideMSA QoL (Motor Domain)53.1—
MSA QoL (Non-motor Domain)37.4—
MSA QoL (Emotional/Social Functioning Domain)33.3—
Standard of CareMSA QoL (Motor Domain)53.7—
MSA QoL (Non-motor Domain)39.3—
MSA QoL (Emotional/Social Functioning Domain)43.1—
Secondary/protocol endpoint

Clinical Global Impression (CGI) Scale

Time frame:48 weeks

PGI, change

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
Exenatide3.1—
Standard of Care2.4—
Secondary/protocol endpoint

Beck Depression Inventory II (BDI-II)

Time frame:48 weeks

change from baseline, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Exenatide14.3—
Standard of Care15.2—

Other clinical outcomes

6 endpoints
Primary/protocol endpoint/low confidence

Change in UMSARS Score (Parts I+II) From Baseline

Time frame:Baseline and 48 weeks

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
Exenatide6.13.0 – 9.3
Standard of Care13.39.2 – 17.3
Secondary/protocol endpoint

Loss of Independent Ambulation

Time frame:48 weeks

threshold achievement, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Exenatide2—
Standard of Care2—
Secondary/protocol endpoint

Number of Falls

Time frame:48 weeks

event count, event

Posted result

GroupValue (mean), Number of falls95% CI
Exenatide1.7—
Standard of Care3.0—
Secondary/protocol endpoint

Milestones on UMSARS Part 1 (Speech, Swallow and Falling)

Time frame:48 weeks

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
ExenatideUMSARS Part 1 Item 1 (Speech)3—
UMSARS Part 1 Item 2 (Swallowing)2—
UMSARS Part 1 Item 8 (Falling)3—
Standard of CareUMSARS Part 1 Item 1 (Speech)7—
UMSARS Part 1 Item 2 (Swallowing)8—
UMSARS Part 1 Item 8 (Falling)6—
Secondary/protocol endpoint

Montreal Cognitive Assessment (MoCA)

Time frame:48 weeks

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
Exenatide26.0—
Standard of Care27.2—
Secondary/protocol endpoint/low confidence

UMSARS Part IV

Time frame:Score at 48 Weeks

descriptive, improvement

Posted result

GroupValue (mean), Score on a scale95% CI
Exenatide2.8—
Standard of Care3.0—

Publications (32)

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

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.