Adults 18 to 74, any sex, with Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-Emergent Adverse EventsPrimary· Up to 70 days
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, as follows: Grade 1 (mild/asymptomatic; no intervention); Grade 2 (moderate; minimal intervention); Grade 3 (severe/medically significant; hospitalization indicated; disabling); Grade 4 (life-threatening; urgent intervention required). Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, and any other medically indicated assessments, including subject interviews, from the tim
Any TEAE
Group
Value
95% CI
Part 1: SYNB1020
4
Part 2: SYNB1020
8
Part 2: Placebo
4
Maximum TEAE severity Grade 1
Group
Value
95% CI
Part 1: SYNB1020
3
Part 2: SYNB1020
3
Part 2: Placebo
1
Maximum TEAE severity Grade 2
Group
Value
95% CI
Part 1: SYNB1020
1
Part 2: SYNB1020
5
Part 2: Placebo
2
Maximum TEAE severity Grade 3
Group
Value
95% CI
Part 1: SYNB1020
0
Part 2: SYNB1020
0
Part 2: Placebo
1
Treatment-related TEAE
Group
Value
95% CI
Part 1: SYNB1020
2
Part 2: SYNB1020
4
Part 2: Placebo
0
TEAE leading to discontinuation
Group
Value
95% CI
Part 1: SYNB1020
0
Part 2: SYNB1020
2
Part 2: Placebo
0
Treatment-related TEAE leading to discontinuation
Group
Value
95% CI
Part 1: SYNB1020
0
Part 2: SYNB1020
0
Part 2: Placebo
0
Serious TEAE
Group
Value
95% CI
Part 1: SYNB1020
0
Part 2: SYNB1020
0
Part 2: Placebo
1
Number of Participants With Clearance of SYNB1020 From FecesSecondary· Up to 65 days
SYNB1020 transit through the gastrointestinal tract was measured with qualitative and quantitative polymerase chain reaction (PCR) fecal assays from fecal samples collected at baseline, daily during the dosing period (Days 1 through 6), at the time of discharge from the inpatient unit (Day 7), and at follow-up visits beginning 7±1 days after the last dose and continuing biweekly until a subject had a negative SYNB1020 fecal test. SYNB1020 clearance reflects a test value of below the limit of quantitation (BLQ) occurring after the indicated number of days following the last dose of study treatm
Group
Value
95% CI
Part 1: SYNB1020
6
Part 2: SYNB1020
9
Part 2: Placebo
0
Part 1: SYNB1020
0
Part 2: SYNB1020
0
Part 2: Placebo
8
Daily Fasting Spot Venous AmmoniaSecondary· Up to 9 days
Fasting spot venous ammonia was collected at baseline (Day -2) and at the time of discharge from the inpatient unit (Day 7).
Baseline
Group
Value
95% CI
Part 1: SYNB1020
64.7
± 25.00
Part 2: SYNB1020
82.0
± 36.41
Part 2: Placebo
55.6
± 18.18
End of Study/Day 7
Group
Value
95% CI
Part 1: SYNB1020
62.3
± 27.57
Part 2: SYNB1020
97.7
± 58.79
Part 2: Placebo
67.9
± 42.69
Adverse events — posted to ClinicalTrials.gov
Time frame: All AEs occurring from the time a subject signs informed consent through the safety follow-up period (i.e.,up to 70 days) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This Phase 1b/2a, randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, and pharmacodynamics of SYNB1020 in hepatic insufficiency and cirrhosis patients with hyperammonemia, with dosing of the investigational medicinal product (IMP) administered in an inpatient unit and subsequent outpatient follow-up for SYNB1020 clearance in two study parts.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07461545 — Efficacy of Apixaban in the Treatment of Portal Vein Thrombosis Occurring More Than One Year After LS
· NA
· recruiting
NCT07461532 — Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD
· NA
· recruiting
NCT07462091 — Vagus Nerve-guided Laparoscopic Splenectomy and Azygoportal Disconnection
· NA
· recruiting
Other Synlogic trials
Trials by the same sponsor.
NCT05764239 — Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)
· Phase 3
· terminated
NCT05462132 — Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers
· Phase 1
· completed
NCT05377112 — Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bow
· EARLY_PHASE1
· completed
NCT04984525 — Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers
· Phase 1
· completed
NCT04629170 — Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Synlogic
Last refreshed: 13 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03447730.