Number of Participants With Adverse Events for TERN-101 Versus Placebo
Primary
· 16 weeks
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 10 | |
| TERN-101 5 mg | 13 | |
| TERN-101 10 mg | 14 | |
| TERN-101 15 mg | 15 |
Last reviewed · How we verify
NCT04328077
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Completed
Phase 2
Results posted
Last updated 9 August 2022
What this trial tests
Phase 2 trial testing TERN-101 in NASH - Nonalcoholic Steatohepatitis in 101 participants. Completed in 19 May 2021.
Timeline
18 June 2020
Primary endpoint
19 May 2021
19 May 2021
19 May 2021
Quick facts
| Lead sponsor | Terns, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 101 |
| Start date | 18 June 2020 |
| Primary completion | 19 May 2021 |
| Estimated completion | 19 May 2021 |
| Sites | 31 locations across United States |
Drugs / interventions tested
- TERN-101 — full drug profile →
- Placebo
Conditions studied
- NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →
Sponsor
Terns, Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with NASH - Nonalcoholic Steatohepatitis. 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.
Percent Change From Baseline in ALT Outcome Measure
Secondary
· 12 weeks
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -5.33 | ± 6.606 |
| TERN-101 5 mg | -2.63 | ± 6.743 |
| TERN-101 10 mg | -17.99 | ± 6.646 |
| TERN-101 15 mg | -13.22 | ± 7.246 |
Plasma Concentration of TERN-101 - AUC 0-24
Secondary
· 12 weeks (0-24 hours post dose)
Area under the curve
| Group | Value | 95% CI |
|---|---|---|
| TERN-101 5mg | 1380 | ± 96.7 |
| TERN-101 10mg | 1470 | ± 29.7 |
| TERN-101 15mg | 2510 | ± 13.3 |
Plasma Concentration of TERN-101 - Cmax
Secondary
· 12 Weeks (0-72 hours post dose)
Maximum observed concentration
| Group | Value | 95% CI |
|---|---|---|
| TERN-101 5 mg | 116 | ± 45.0 |
| TERN-101 10 mg | 155 | ± 158.8 |
| TERN-101 15 mg | 389 | ± 19.0 |
Plasma Concentration of TERN-101 - Tmax
Secondary
· 12 Weeks (0-72 hours post dose)
Time to reach maximum measured plasma concentration
| Group | Value | 95% CI |
|---|---|---|
| TERN-101 5 mg | 1 | 0 – 6 |
| TERN-101 10 mg | 1 | 0 – 3 |
| TERN-101 15 mg | 0.5 | 0.5 – 1 |
Plasma Concentration of TERN-101 - t1/2
Secondary
· 12 Weeks (0-72 hours post dose)
Determination of half-life
| Group | Value | 95% CI |
|---|---|---|
| TERN-101 5 mg | 14.6 | 8.7 – 67.8 |
| TERN-101 10 mg | 6.75 | 4 – 7.9 |
| TERN-101 15 mg | 6 | 5.8 – 11.3 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 16 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 1/26 (4%)
Deaths: 0/26
TERN-101 5mg
Serious: 0/25 (0%)
Deaths: 0/25
TERN-101 10mg
Serious: 0/26 (0%)
Deaths: 0/26
TERN-101 15mg
Serious: 1/23 (4%)
Deaths: 0/23
Serious adverse events (2 terms)
| Reaction | System | Placebo | TERN-101 5mg | TERN-101 10mg | TERN-101 15mg |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
Other adverse events (59 terms — click to expand)
| Reaction | System | Placebo | TERN-101 5mg | TERN-101 10mg | TERN-101 15mg |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| COVID-19 | Infections and infestations | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — |
| Asymptomatic COVID-19 | Infections and infestations | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
| Tooth infection | Infections and infestations | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Abdominal pain lower | Gastrointestinal disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Asthenia | General disorders | — | — | — | — |
| Blood glucose increased | Investigations | — | — | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — | — | — |
| Conjunctivitis | Infections and infestations | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Diabetes mellitus | Metabolism and nutrition disorders | — | — | — | — |
| Early satiety | General disorders | — | — | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — | — | — |
| Faecaloma | General disorders | — | — | — | — |
| Flatulence | General disorders | — | — | — | — |
| Frequent bowel movements | Gastrointestinal disorders | — | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Hepatic enzyme increased | Investigations | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Hypoglycaemia | Metabolism and nutrition disorders | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — |
| Influenza like illness | General disorders | — | — | — | — |
| Injection site pain | General disorders | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Lethargy | Nervous system disorders | — | — | — | — |
| Magnetic resonance imaging abnormal | Investigations | — | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — |
Most-reported serious reactions: COVID-19 pneumonia, Urinary tract infection.
Data from ClinicalTrials.gov NCT04328077 adverse events section.
Sponsor's own description
This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting fibrosis, mechanisms and cilinical trials.
Zhao M, Wang L, Wang M, Zhou S, et al · · 2022 · cited 352× · PMID 35773269 · DOI 10.1038/s41392-022-01070-3 -
Bile acid metabolism and signaling in health and disease: molecular mechanisms and therapeutic targets.
Fleishman JS, Kumar S. · · 2024 · cited 267× · PMID 38664391 · DOI 10.1038/s41392-024-01811-6 -
Farnesoid X receptor (FXR): Structures and ligands.
Jiang L, Zhang H, Xiao D, Wei H, et al · · 2021 · cited 173× · PMID 33995909 · DOI 10.1016/j.csbj.2021.04.029 -
Gut liver brain axis in diseases: the implications for therapeutic interventions.
Yan M, Man S, Sun B, Ma L, et al · · 2023 · cited 165× · PMID 38057297 · DOI 10.1038/s41392-023-01673-4 -
Transcriptional Regulation of Metabolic Pathways via Lipid-Sensing Nuclear Receptors PPARs, FXR, and LXR in NASH.
Cariello M, Piccinin E, Moschetta A. · · 2021 · cited 71× · PMID 33545430 · DOI 10.1016/j.jcmgh.2021.01.012 -
FXR: structures, biology, and drug development for NASH and fibrosis diseases.
Tian SY, Chen SM, Pan CX, Li Y. · · 2022 · cited 65× · PMID 35217809 · DOI 10.1038/s41401-021-00849-4 -
Bile Acid Receptors and the Gut-Liver Axis in Nonalcoholic Fatty Liver Disease.
Xue R, Su L, Lai S, Wang Y, et al · · 2021 · cited 65× · PMID 34831031 · DOI 10.3390/cells10112806 -
Obesity, non-alcoholic fatty liver disease and hepatocellular carcinoma: current status and therapeutic targets.
Chen Y, Wang W, Morgan MP, Robson T, et al · · 2023 · cited 37× · PMID 37361533 · DOI 10.3389/fendo.2023.1148934
Verify or expand the search:
- PubMed search for NCT04328077
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TERN-101
Trials testing the same drug.
- NCT05415722 — DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administe · Phase 2 · completed
Other recruiting trials for NASH - Nonalcoholic Steatohepatitis
Currently open trials in the same condition.
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- NCT05023044 — Nonalcoholic Fatty Liver Disease in HIV Database · active not recruiting
- NCT04232566 — Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity · recruiting
- NCT05165446 — Novel MRE Technique to Assess a Risk Factor for Liver Cancer · active not recruiting
- NCT04697810 — Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH) · Phase 2 · recruiting
Other Terns, Inc. trials
Trials by the same sponsor.
- NCT06854952 — A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity · Phase 2 · completed
- NCT06163430 — A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participa · Phase 1, PHASE2 · recruiting
- NCT05415722 — DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administe · Phase 2 · completed
- NCT04897594 — AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04328077 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Terns, Inc.
- Last refreshed: 9 August 2022
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/NCT04328077.
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