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sponsor decision
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| Name | Class |
|---|---|
| ProSciento, Inc. | INDUSTRY |
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This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH.
The study may be conducted in up to 2 dosing cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental |
| |
| Cohort B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT-4101 | Drug | FT-4101 will be supplied as active capsules and will be administered per the protocol defined frequency and dose level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as an adverse events (AEs) with an onset that occurred after receiving the first dose of the study drug (AE start date greater than or equal to [>=] first dose date) and within 30 days after receiving the last dose of the study drug (AE start date - last dose date less than or equal to [<=] 30). Number of participants with TEAEs are reported. | From start of study drug administration up to 20 weeks |
| Number of Participants With Clinically Significant Changes in Laboratory Values | Number of participants with clinically significant changes in laboratory values (hematology, serum chemistry, and urinalysis) are reported. | Up to 20 weeks |
| Number of Participants With Clinically Significant Changes in Physical Examination | Number of participants with clinically significant changes in physical examination are reported. | Up to 20 weeks |
| Change From Baseline in Vital Signs: Blood Pressure (BP) | Change from baseline in blood pressure (systolic and diastolic) are reported. | Baseline, Day 92 |
| Change From Baseline in Vital Signs: Heart Rate (HR) | Change from baseline in heart rate is reported. | Baseline, Day 92 |
| Change From Baseline in Vital Signs: Respiratory Rate | Change from baseline in respiratory rate is reported. | Baseline, Day 92 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Liver Fat on MRI-PDFF | Change from baseline in percentage of liver fat on MRI-PDFF is reported. | At week 6 |
| Percent Change From Baseline in Liver Fat on MRI-PDFF | Percent change from baseline in liver fat on MRI-PDFF is reported. |
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Key Inclusion Criteria:
Meets all of the following criteria:
Body mass index (BMI) > 25.0 to < 45.0 kg/m2
Stable body weight
Subjects with T2DM may also be included, if:
Waist circumference ≤ 57 inches
Female subjects must be non-pregnant and non-lactating
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834), MD | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProSciento, Inc. | Chula Vista | California | 91911 | United States | ||
| Catalina Research Institute |
Participants were randomized at a ratio of 2:1 in FT-4101 treatment group and placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | FT-4101 3.0 mg | Participants received 3.0 mg of FT-4101 capsule orally once daily for 2 weeks, followed by 1 week of no treatment. This cycle continued until the end of week 12, for up to 4 dosing cycle (each cycle 21 days). |
| FG001 | Placebo | Participants received FT-4101 matching placebo capsule orally once daily for 2 weeks, followed by 1 week of no treatment. This cycle continued until the end of week 12, for up to 4 dosing cycle (each cycle 21 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Randomized analysis set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | FT-4101 3.0 mg | Participants received 3.0 mg of FT-4101 capsule orally once daily for 2 weeks, followed by 1 week of no treatment. This cycle continued until the end of week 12, for up to 4 dosing cycle (each cycle 21 days). |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as an adverse events (AEs) with an onset that occurred after receiving the first dose of the study drug (AE start date greater than or equal to [>=] first dose date) and within 30 days after receiving the last dose of the study drug (AE start date - last dose date less than or equal to [<=] 30). Number of participants with TEAEs are reported. | The Safety analysis set included all randomized participants who received investigational product (IP) (FT-4101 or placebo) or deuterated water. | Posted | Count of Participants | Participants | From start of study drug administration up to 20 weeks |
|
From start of study drug administration up to 20 weeks
The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FT-4101 3.0 mg | Participants received 3.0 mg of FT-4101 capsule orally once daily for 2 weeks, followed by 1 week of no treatment. This cycle continued until the end of week 12, for up to 4 dosing cycle (each cycle 21 days). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA version 22.0. | Systematic Assessment |
The study was planned for two dosing cohorts (Cohort A and Cohort B), but only Cohort A was included. The study terminated because of observed insufficient efficacy with the studied dose to warrant further investigation. The 3 mg dose didn't raise safety concerns, but to achieve a meaningful result, higher doses would exceed the safe limit based on past studies. Therefore, it was determined that further evaluation of FT-4101 dose escalations for the study indication was not appropriate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | FORMA Therapeutics, Inc. | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 23, 2019 | Oct 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2019 | Oct 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D044343 | Overnutrition |
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| FT-4101 placebo | Drug | FT-4101 placebo will be supplied as placebo capsule matching in size and color to all the active capsules and will be administered per the protocol defined frequency and dose level. |
|
| Deuterated Water | Other | Deuterated water will be provided as individual ready-to-use, single dose bottles each containing 50 mL of deuterated water (70%). |
|
| Change From Baseline in Vital Signs: Temperature |
Change from baseline in temperature is reported. |
| Baseline, Day 92 |
| Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: ECG Mean Heart Rate | Change from baseline in ECG mean heart rate is reported. | Baseline, Day 92 |
| Change From Baseline in 12-lead ECG Parameters: QT Interval | Change from baseline in QT interval is reported. | Baseline, Day 92 |
| Change From Baseline in 12-lead ECG Parameters: PR Interval | Change from baseline in PR interval is reported. | Baseline, Day 92 |
| Change From Baseline in 12-lead ECG Parameters: QRS Interval | Change from baseline in QRS interval is reported. | Baseline, Day 92 |
| Change From Baseline in 12-lead ECG Parameters: RR Interval | Change from baseline in RR interval is reported. | Baseline, Day 92 |
| Change From Baseline in 12-lead ECG Parameters: QTc (Corrected) Using the Fridericia Correction (QTcF) Interval | Change from baseline in QTcF interval is reported. | Baseline, Day 92 |
| Percent Change From Baseline in Liver Fat on Magnetic Resonance Imaging- Proton Density Fat Fraction (MRI-PDFF) | Percent change from baseline in liver fat on MRI-PDFF is reported. | At week 12 |
| Change From Baseline in Liver Fat on Magnetic Resonance Imaging- Proton Density Fat Fraction (MRI-PDFF) | Change from baseline in percentage of liver fat on MRI-PDFF is reported. | At week 12 |
| At week 6 |
| Percentage of Participants Experiencing a Relative Reduction of 30% or Greater of Liver Fat as Assessed by MRI-PDFF | Percentage of participants experiencing a relative reduction of 30% or greater of liver fat as assessed by MRI-PDFF at week 12 are reported. | At week 12 |
| Change From Baseline in Alanine Aminotransferase (ALT) | Change from baseline in ALT is reported. | Baseline, Day 92 |
| Change From Baseline in Aspartate Aminotransferase (AST) | Change from baseline in AST is reported. | Baseline, Day 92 |
| Change From Baseline in Gamma-glutamyl Transferase (γGT) | Change from baseline in γGT is reported. | Baseline, Day 92 |
| Change From Baseline in Alkaline Phosphatase | Change from baseline in alkaline phosphatase is reported. | Baseline, Day 92 |
| Change From Baseline in Total Bilirubin | Change from baseline in total bilirubin is reported. | Baseline, Day 92 |
| Maximum Plasma Concentration (Cmax) of FT-4101 | Maximum plasma concentration (Cmax) of FT-4101 is reported | Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days |
| Area Under the Concentration-time Curve for a Dosing Interval (AUCtau) of FT-4101 | Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days |
| Data for This Endpoint Was Not Collected and Analysed. | Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days |
| Montclair |
| California |
| 91763 |
| United States |
Participants received FT-4101 matching placebo capsule orally once daily for 2 weeks, followed by 1 week of no treatment. This cycle continued until the end of week 12, for up to 4 dosing cycle (each cycle 21 days). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo | Participants received FT-4101 matching placebo capsule orally once daily for 2 weeks, followed by 1 week of no treatment. This cycle continued until the end of week 12, for up to 4 dosing cycle (each cycle 21 days). |
|
|
| Primary | Number of Participants With Clinically Significant Changes in Laboratory Values | Number of participants with clinically significant changes in laboratory values (hematology, serum chemistry, and urinalysis) are reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Count of Participants | Participants | Up to 20 weeks |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes in Physical Examination | Number of participants with clinically significant changes in physical examination are reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Count of Participants | Participants | Up to 20 weeks |
|
|
|
| Primary | Change From Baseline in Vital Signs: Blood Pressure (BP) | Change from baseline in blood pressure (systolic and diastolic) are reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, Day 92 |
|
|
|
| Primary | Change From Baseline in Vital Signs: Heart Rate (HR) | Change from baseline in heart rate is reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Mean | Standard Deviation | Beats per minutes (beats/min) | Baseline, Day 92 |
|
|
|
| Primary | Change From Baseline in Vital Signs: Respiratory Rate | Change from baseline in respiratory rate is reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Mean | Standard Deviation | Breaths per minute (breaths/min) | Baseline, Day 92 |
|
|
|
| Primary | Change From Baseline in Vital Signs: Temperature | Change from baseline in temperature is reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Mean | Standard Deviation | Degree Celsius (C) | Baseline, Day 92 |
|
|
|
| Primary | Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: ECG Mean Heart Rate | Change from baseline in ECG mean heart rate is reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Mean | Standard Deviation | beats/min | Baseline, Day 92 |
|
|
|
| Primary | Change From Baseline in 12-lead ECG Parameters: QT Interval | Change from baseline in QT interval is reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Mean | Standard Deviation | milliseconds (msec) | Baseline, Day 92 |
|
|
|
| Primary | Change From Baseline in 12-lead ECG Parameters: PR Interval | Change from baseline in PR interval is reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Mean | Standard Deviation | msec | Baseline, Day 92 |
|
|
|
| Primary | Change From Baseline in 12-lead ECG Parameters: QRS Interval | Change from baseline in QRS interval is reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Mean | Standard Deviation | msec | Baseline, Day 92 |
|
|
|
| Primary | Change From Baseline in 12-lead ECG Parameters: RR Interval | Change from baseline in RR interval is reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Mean | Standard Deviation | msec | Baseline, Day 92 |
|
|
|
| Primary | Change From Baseline in 12-lead ECG Parameters: QTc (Corrected) Using the Fridericia Correction (QTcF) Interval | Change from baseline in QTcF interval is reported. | The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water. | Posted | Mean | Standard Deviation | msec | Baseline, Day 92 |
|
|
|
| Primary | Percent Change From Baseline in Liver Fat on Magnetic Resonance Imaging- Proton Density Fat Fraction (MRI-PDFF) | Percent change from baseline in liver fat on MRI-PDFF is reported. | The preliminary efficacy analysis set included all participants who received FT-4101 or placebo with at least one quantifiable baseline and one post-baseline MRI-PDFF without major protocol deviations or violations that would have an impact on pharmacodynamics (PD) (Specifically MRI-PDFF). | Posted | Mean | Standard Deviation | Percent change of liver fat | At week 12 |
|
|
|
| Primary | Change From Baseline in Liver Fat on Magnetic Resonance Imaging- Proton Density Fat Fraction (MRI-PDFF) | Change from baseline in percentage of liver fat on MRI-PDFF is reported. | The preliminary efficacy analysis set included all participants who received FT-4101 or placebo with at least one quantifiable baseline and one post-baseline MRI-PDFF without major protocol deviations or violations that would have an impact on PD (Specifically MRI-PDFF). | Posted | Mean | Standard Deviation | Percentage of liver fat | At week 12 |
|
|
|
| Secondary | Change From Baseline in Liver Fat on MRI-PDFF | Change from baseline in percentage of liver fat on MRI-PDFF is reported. | The preliminary efficacy analysis set included all participants who received FT-4101 or placebo with at least one quantifiable baseline and one post-baseline MRI-PDFF without major protocol deviations or violations that would have an impact on PD (Specifically MRI-PDFF). | Posted | Mean | Standard Deviation | Percentage of liver fat | At week 6 |
|
|
|
| Secondary | Percent Change From Baseline in Liver Fat on MRI-PDFF | Percent change from baseline in liver fat on MRI-PDFF is reported. | The preliminary efficacy analysis set included all participants who received FT-4101 or placebo with at least one quantifiable baseline and one post-baseline MRI-PDFF without major protocol deviations or violations that would have an impact on PD (Specifically MRI-PDFF). | Posted | Mean | Standard Deviation | Percent change of liver fat | At week 6 |
|
|
|
| Secondary | Percentage of Participants Experiencing a Relative Reduction of 30% or Greater of Liver Fat as Assessed by MRI-PDFF | Percentage of participants experiencing a relative reduction of 30% or greater of liver fat as assessed by MRI-PDFF at week 12 are reported. | The preliminary efficacy analysis set included all participants who received FT-4101 or placebo with at least one quantifiable baseline and one post-baseline MRI-PDFF without major protocol deviations or violations that would have an impact on PD (Specifically MRI-PDFF). | Posted | Number | Percentage of participants | At week 12 |
|
|
|
| Secondary | Change From Baseline in Alanine Aminotransferase (ALT) | Change from baseline in ALT is reported. | The pharmacodynamic (PD) analysis set was to include all participants who received FT-4101 or placebo without major protocol deviations or violations that would have had an impact on PD. | Posted | Least Squares Mean | Standard Error | units per liter (U/L) | Baseline, Day 92 |
|
|
|
| Secondary | Change From Baseline in Aspartate Aminotransferase (AST) | Change from baseline in AST is reported. | The pharmacodynamic (PD) analysis set was to include all participants who received FT-4101 or placebo without major protocol deviations or violations that would have had an impact on PD. | Posted | Least Squares Mean | Standard Error | U/L | Baseline, Day 92 |
|
|
|
| Secondary | Change From Baseline in Gamma-glutamyl Transferase (γGT) | Change from baseline in γGT is reported. | The pharmacodynamic (PD) analysis set was to include all participants who received FT-4101 or placebo without major protocol deviations or violations that would have had an impact on PD. | Posted | Least Squares Mean | Standard Error | U/L | Baseline, Day 92 |
|
|
|
| Secondary | Change From Baseline in Alkaline Phosphatase | Change from baseline in alkaline phosphatase is reported. | The pharmacodynamic (PD) analysis set was to include all participants who received FT-4101 or placebo without major protocol deviations or violations that would have had an impact on PD. | Posted | Least Squares Mean | Standard Error | U/L | Baseline, Day 92 |
|
|
|
| Secondary | Change From Baseline in Total Bilirubin | Change from baseline in total bilirubin is reported. | The pharmacodynamic (PD) analysis set was to include all participants who received FT-4101 or placebo without major protocol deviations or violations that would have had an impact on PD. | Posted | Least Squares Mean | Standard Error | micromoles per liter (umol/L) | Baseline, Day 92 |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of FT-4101 | Maximum plasma concentration (Cmax) of FT-4101 is reported | The pharmacokinetic (PK) analysis set included all participants who received FT-4101 with sufficient evaluable PK concentration data appropriate for the evaluation of interest without major protocol deviations or violations that would have an impact on the absorption, distribution, metabolism, or excretion. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days |
|
|
|
| Secondary | Area Under the Concentration-time Curve for a Dosing Interval (AUCtau) of FT-4101 | Data for this endpoint was not collected and analysed as there were no participants. | Posted | Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days |
|
|
|
| Secondary | Data for This Endpoint Was Not Collected and Analysed. | Data for this endpoint was not collected and analysed as there were no participants. | Posted | Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | Placebo | Participants received FT-4101 matching placebo capsule orally once daily for 2 weeks, followed by 1 week of no treatment. This cycle continued until the end of week 12, for up to 4 dosing cycle (each cycle 21 days). | 0 | 5 | 0 | 5 | 3 | 5 |
| Gastroenteritis | Infections and infestations | MedDRA version 22.0. | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 22.0. | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 22.0. | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA version 22.0. | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 22.0. | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 22.0. | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA version 22.0. | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 22.0. | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |