Trial · NCT07052682
A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4
NCT07052682, Phase 1, Terminated, Takeda; results first posted 2025-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4. Trials, record NCT07052682. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07052682
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4
- NCT number
- NCT07052682
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 11 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Steatohepatitis
- Interventions
- Ontamalimab
- First posted
- 2025-07-06
- Last updated
- 2025-08-19
- Results first posted
- 2025-08-19
- Limitations and caveats
- The study was terminated early by the sponsor due to a strategic shift and reprioritization of clinical programs within Takeda.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug up to Week 36 | An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs was defined as any event that emerged or manifested at or after the initiation of treatment with a study drug or medicinal product, or any existing event that worsened in either intensity or frequency following exposure to the study drug or medicinal product. |
| Primary | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | From first dose of study drug up to Week 36 | Laboratory parameters included serum chemistry, hematology, urinalysis, and coagulation. Any Abnormality in clinical laboratory results which are deemed clinically significant by the investigator were reported. |
| Primary | Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECGs) Findings | From first dose of study drug up to Week 24 | ECG included heart rate, QRS intervals, QT intervals, PR intervals, RR intervals and QT intervals corrected for heart rate using Fridericia's formula (QTcF) intervals parameters measurement. Any abnormality in ECG assessments which were deemed clinically significant by the investigator were reported. |
| Primary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | From first dose of study drug up to 36 weeks | Vital signs included measurement of pulse rate, systolic, diastolic blood pressure, respiratory rate, Body mass index (BMI), body temperature and height. Any abnormality in vital signs which are deemed clinically significant by the investigator were reported. |
| Primary | Number of Participants With Clinically Significant Abnormalities in Body Weight | From first dose of study drug up to Week 36 | Body weight was measured in kilograms (kg) at the specified time points. Any abnormality in body weight which are deemed clinically significant by the investigator were reported. |
| Secondary | Percent Change From Baseline in Pro-Collagen Type III (Pro-C3) Through Week 24 | Baseline up to Week 24 | Researchers measured the change in liver scarring using biomarkers. Biomarkers are substances measured in blood that show normal or abnormal activity taking place in the liver. Pro-C3 was measured in serum; Increasing levels indicate worsening of fibrosis activity. Blood samples were collected for assessment of Pro-C3 biomarker. |
| Secondary | Percent Change From Baseline in Enhanced Liver Fibrosis (ELF) Through Week 24 | Baseline up to Week 24 | Researchers measured the change in liver scarring using biomarkers. Biomarkers are substances measured in blood that show normal or abnormal activity taking place in the liver. Blood samples were collected for an assessment of ELF score. The ELF score was calculated from the concentrations of the following serum biomarkers: tissue inhibitor of metalloproteinases- 1 (TIMP-1), procollagen III n-terminal propeptide (PIIINP), and hyaluronic acid (HA). ELF was a score on a scale of severity assessment against biopsy-proven fibrosis. A score of less than (\<) 7.7 is none to mild, greater than (\>) 7.7-9.8 is moderate, \>9.8 is severe. Higher ELF scores represented worse disease outcome. |
| Secondary | Change From Baseline in Liver Iron-corrected T1 Mapping by Magnetic Resonance Imaging (cT1 MRI) at Week 24 | Baseline, Week 24 | cT1 is a quantitative MRI relaxation parameter that measures liver inflammation and fibrosis. Participants underwent abdominal MRI to obtain liver cT1, which were used to assess fibro-inflammation. The change from baseline was calculated by subtracting the baseline values from the individual post-baseline values. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug up to Week 36 | The safety analysis set consisted of all participants who were enrolled in the study and had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | From first dose of study drug up to Week 36 | The safety analysis set consisted of all participants who were enrolled in the study and had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECGs) Findings | From first dose of study drug up to Week 24 | The safety analysis set consisted of all participants who were enrolled in the study and had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Vital Signs | From first dose of study drug up to 36 weeks | The safety analysis set consisted of all participants who were enrolled in the study and had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Body Weight | From first dose of study drug up to Week 36 | The safety analysis set consisted of all participants who were enrolled in the study and had received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Pro-Collagen Type III (Pro-C3) Through Week 24 | Baseline up to Week 24 | The full analysis set (FAS) consisted of all participants who were enrolled in the study, had received at least one dose of the study drug, and had at least one valid postbaseline assessment. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Enhanced Liver Fibrosis (ELF) Through Week 24 | Baseline up to Week 24 | The FAS consisted of all participants who were enrolled in the study, had received at least one dose of the study drug, and had at least one valid postbaseline assessment. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Liver Iron-corrected T1 Mapping by Magnetic Resonance Imaging (cT1 MRI) at Week 24 | Baseline, Week 24 | The FAS consisted of all participants who were enrolled in the study, had received at least one dose of the study drug, and had at least one valid postbaseline assessment. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | millisecond (ms) | MEAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Ontamalimab | 6 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | Ontamalimab | Serum Chemistry | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | Ontamalimab | Hematology | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | Ontamalimab | Urinalysis | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values | Ontamalimab | Coagulation | 0 | Participants | |
| Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECGs) Findings | Ontamalimab | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Ontamalimab | 0 | Participants | ||
| Number of Participants With Clinically Significant Abnormalities in Body Weight | Ontamalimab | 0 | Participants | ||
| Percent Change From Baseline in Pro-Collagen Type III (Pro-C3) Through Week 24 | Ontamalimab | -11.88 | 95% Confidence Interval -26.13 to 2.37 | percent change | |
| Percent Change From Baseline in Enhanced Liver Fibrosis (ELF) Through Week 24 | Ontamalimab | -0.13 | 95% Confidence Interval -3.61 to 3.35 | percent change |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ontamalimab | 11 | |
| Overall Study | COMPLETED | Ontamalimab | 7 | |
| Overall Study | NOT COMPLETED | Ontamalimab | 4 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Ontamalimab | 1 | 11 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Ontamalimab | 1 | 11 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Ontamalimab | 1 | 11 | |
| other | Dizziness | Nervous system disorders | Ontamalimab | 1 | 11 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Ontamalimab | 1 | 11 | |
| other | Headache | Nervous system disorders | Ontamalimab | 1 | 11 | |
| other | Hot flush | Vascular disorders | Ontamalimab | 2 | 11 | |
| other | Hypertension | Vascular disorders | Ontamalimab | 1 | 11 | |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Ontamalimab | 1 | 11 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Ontamalimab | 1 | 11 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ontamalimab | 0 | 11 |
| Total, other adverse events | Ontamalimab | 6 | 11 |
| Total, serious adverse events | Ontamalimab | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07052682
GET https://conductscience.org/api/trials/v1/NCT07052682/registered