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Active not recruitingPhase 4

A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)

A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules

Lead sponsor

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Asset

Sodium oligomannate

Listed sites

Recruiting sites

Enrollment

2,500

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥18

Primary endpoint

•Long-term safety of GV-971 in clinical practice

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

Org study IDGV-971-PMS-A

NCT IDNCT05058040

Timeline

Milestones

Study start2021-06-02actual

Study first posted2021-09-27actual

Primary completion2025-01estimated (month precision)

Last update posted2025-01-24actual

Study completion2025-04estimated (month precision)

Assets

Drug assets

Sodium oligomannate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subjects eligible for this study must meet all of the following criteria:

1. ≥18 years of age;

2. Signed informed consent form;

3. Patients receiving GV-971 treatment prescribed by clinicians

Exclusion criteria

•A subject may be excluded from participation in the study if any of the following apply:

1. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;

2. Female participants who are pregnant or lactating;

3. Patients who cannot cooperate to complete the follow-up inquiries;

4. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.

Endpoints (4)

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.

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Long-term safety of GV-971 in clinical practice during 48 weeks

Time frame:Week 48

event count, event

Primary/protocol endpoint

Long-term safety of GV-971 in clinical practice during 96 weeks

Time frame:Week 96

event count, event

Secondary/protocol endpoint

Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 48 weeks

Time frame:48-week

event count, event

Secondary/protocol endpoint

Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 96 weeks

Time frame:96-week

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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 21, 2026 snapshot.