Trial Outcomes & Findings for 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 NCT07052682)

NCT ID: NCT07052682

Last Updated: 2025-08-19

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 11 participants
• Primary outcome timeframe: From first dose of study drug up to Week 36
• Results posted on: 2025-08-19

Participant Flow

Participants took part in the study at 20 investigative sites in the United States from 18 January 2023 to 30 December 2024.

A total of 11 participants were enrolled and received study treatment. The study was terminated early by the sponsor due to a strategic shift and reprioritization of clinical programs within Takeda.

Participant milestones

Measure	Ontamalimab Participants received ontamalimab 75 milligrams (mg) subcutaneous (SC) injection using a prefilled syringe once every 4 weeks (Q4W) on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Overall Study STARTED	11
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Ontamalimab Participants received ontamalimab 75 milligrams (mg) subcutaneous (SC) injection using a prefilled syringe once every 4 weeks (Q4W) on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4

Baseline characteristics by cohort

Measure	Ontamalimab n=11 Participants Participants received ontamalimab 75 mg SC injection using a prefilled syringe Q4W on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Age, Continuous	49.3 years STANDARD_DEVIATION 7.03 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 36

Population: The safety analysis set consisted of all participants who were enrolled in the study and had received at least 1 dose of study drug.

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.

Outcome measures

Measure	Ontamalimab n=11 Participants Participants received ontamalimab 75 mg SC injection using a prefilled syringe Q4W on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	6 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 36

Population: The safety analysis set consisted of all participants who were enrolled in the study and had received at least 1 dose of study drug.

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.

Outcome measures

Measure	Ontamalimab n=11 Participants Participants received ontamalimab 75 mg SC injection using a prefilled syringe Q4W on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Serum Chemistry	0 Participants
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Hematology	0 Participants
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Urinalysis	0 Participants
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Coagulation	0 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 24

Population: The safety analysis set consisted of all participants who were enrolled in the study and had received at least 1 dose of study drug.

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.

Outcome measures

Measure	Ontamalimab n=11 Participants Participants received ontamalimab 75 mg SC injection using a prefilled syringe Q4W on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECGs) Findings	0 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 36 weeks

Population: The safety analysis set consisted of all participants who were enrolled in the study and had received at least 1 dose of study drug.

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.

Outcome measures

Measure	Ontamalimab n=11 Participants Participants received ontamalimab 75 mg SC injection using a prefilled syringe Q4W on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Number of Participants With Clinically Significant Abnormalities in Vital Signs	0 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 36

Population: The safety analysis set consisted of all participants who were enrolled in the study and had received at least 1 dose of study drug.

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.

Outcome measures

Measure	Ontamalimab n=11 Participants Participants received ontamalimab 75 mg SC injection using a prefilled syringe Q4W on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Number of Participants With Clinically Significant Abnormalities in Body Weight	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: 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.

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.

Outcome measures

Measure	Ontamalimab n=8 Participants Participants received ontamalimab 75 mg SC injection using a prefilled syringe Q4W on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Percent Change From Baseline in Pro-Collagen Type III (Pro-C3) Through Week 24	-11.88 percent change Interval -26.13 to 2.37

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: 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.

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.

Outcome measures

Measure	Ontamalimab n=8 Participants Participants received ontamalimab 75 mg SC injection using a prefilled syringe Q4W on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Percent Change From Baseline in Enhanced Liver Fibrosis (ELF) Through Week 24	-0.13 percent change Interval -3.61 to 3.35

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: 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.

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.

Outcome measures

Measure	Ontamalimab n=10 Participants Participants received ontamalimab 75 mg SC injection using a prefilled syringe Q4W on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Change From Baseline in Liver Iron-corrected T1 Mapping by Magnetic Resonance Imaging (cT1 MRI) at Week 24	-32.0 millisecond (ms) Standard Deviation 39.77

Adverse Events

Ontamalimab

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ontamalimab n=11 participants at risk Participants received ontamalimab 75 mg SC injection using a prefilled syringe Q4W on Day 1 and the last dose was administered at Week 20 with a total treatment period of 24 weeks.
Gastrointestinal disorders Abdominal pain upper	9.1% 1/11 • From first dose of study drug up to Week 36
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 1/11 • From first dose of study drug up to Week 36
Metabolism and nutrition disorders Decreased appetite	9.1% 1/11 • From first dose of study drug up to Week 36
Nervous system disorders Dizziness	9.1% 1/11 • From first dose of study drug up to Week 36
Gastrointestinal disorders Gastrooesophageal reflux disease	9.1% 1/11 • From first dose of study drug up to Week 36
Nervous system disorders Headache	9.1% 1/11 • From first dose of study drug up to Week 36
Vascular disorders Hot flush	18.2% 2/11 • From first dose of study drug up to Week 36
Vascular disorders Hypertension	9.1% 1/11 • From first dose of study drug up to Week 36
Metabolism and nutrition disorders Hypoglycaemia	9.1% 1/11 • From first dose of study drug up to Week 36
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11 • From first dose of study drug up to Week 36
Gastrointestinal disorders Nausea	9.1% 1/11 • From first dose of study drug up to Week 36
Musculoskeletal and connective tissue disorders Osteoarthritis	9.1% 1/11 • From first dose of study drug up to Week 36
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • From first dose of study drug up to Week 36
Injury, poisoning and procedural complications Tooth fracture	9.1% 1/11 • From first dose of study drug up to Week 36
Infections and infestations Urinary tract infection	9.1% 1/11 • From first dose of study drug up to Week 36
Infections and infestations Vulvovaginal candidiasis	9.1% 1/11 • From first dose of study drug up to Week 36

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place