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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002491-40 | EudraCT Number |
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Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)).
This non-confirmatory Phase 2 study was designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes and nephropathy.
This was a non-confirmatory, multicenter, patient- and investigator-blinded, randomized, and placebo-controlled, proof-of concept trial assessing nidufexor vs. placebo in patients receiving standard of care (optimal tolerated doses of ARB or ACEI) for diabetic nephropathy due to type 2 diabetes.
The study consisted of three distinct study periods:
Screening (Day -30 to Day-1): lasted up to a maximum of 30 days and comprised a screening / baseline assessment. This visit was used to confirm that the study inclusion and exclusion criteria were met and served as baseline assessment prior to randomization. Participant randomization occurred prior to day 1 as soon as participant eligibility was confirmed.
Treatment period (Day 1-168): Participants were randomized in a 1:1 ratio to receive nidufexor 50 mg or placebo once daily for 24 weeks. Nidufexor and placebo were given in addition to SoC (optimal tolerated doses of ARB or ACEI).
End of Study (EOS) and Safety follow-up (Day 169 to Day 197): Study assessments were performed until the EOS visit (Day 169). Post Study Safety Contact occurred approximately 28 days after discontinuing study treatment until day 197.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMB763 | Experimental | 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC. |
|
| Placebo | Placebo Comparator | Placebo was orally administered once daily for 24 weeks in addition to SoC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nidufexor | Drug | 50 mg (two 25 mg) LMB763 capsules for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) | UACR is a ratio between albumin and creatinine, and it estimates 24-hour urine albumin excretion. UACR (mg/mmol) = urine albumin [mg/L] / urine creatinine [mmol/L]. UACR was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement. | Baseline and days 14, 29, 57, 85, 113, 141 and 169 |
| Ratio to Baseline in 24 Hour Urinary Albumin at Week 24 (Day 169) | Albuminuria describes the existence of albumin in the urine and the gold-standard to assess albuminuria is 24-hour urinary albumin excretion (milligram/24 hours). An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline 24-hour urinary albumin excretion. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement. | Baseline and day 169 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The category Number of participants with AEs includes also the number of participants with SAEs. The number of participants in each category is reported in the table. | From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR) | Estimate Glomerular Filtration Rate (GFR) calculates estimated GFR (eGFR) from serum creatinine levels to assess kidney function. eGFR (milliliter/minute) was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A higher score in the ratio to baseline indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Miami Lakes | Florida | 33014 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
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Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Participants underwent a Screening period of up to 30 days which included screening and baseline assessments.
Participants were recruited from 18 sites in 7 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | LMB763 | 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC. |
| FG001 | Placebo | Placebo was orally administered once daily for 24 weeks in addition to SoC. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 27, 2020 | Apr 27, 2022 |
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| Placebo | Other | Placebo capsules for oral administration |
|
| Standard of Care (SoC) | Drug | Optimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) |
|
| Baseline and days 14, 29, 57, 85, 113, 141 and 169 |
| Maximum Peak Observed Concentration (Cmax) of LMB763 | Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Cmax was determined using non-compartmental methods. No methods for imputation of missing data were used. | pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14 |
| Time to Reach Maximum Blood Concentrations (Tmax) of LMB763 | Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Tmax was determined using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment). No methods for imputation of missing data were used. | pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14 |
| Area Under the Blood Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of LMB763 | Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUClast was determined using non-compartmental methods. No methods for imputation of missing data were used. | pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14 |
| Ratio to Baseline in Free Water Clearance | The free water clearance (mL/min) was calculated using the following formula: (Total Volume (mL) / Elapsed Date & Time (min)) * (1-24 hr Urine Osmolality (mOsmol/kg)/ Serum Osmolality (mOsmol/kg)) The result of free water clearance was rounded to one decimal place prior to statistical analysis. An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline free water clearance. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A higher score in the ratio to baseline indicates improvement. | Baseline and day 169 |
| Ratio to Baseline in Lipoprotein A at Day 85 | Lipoprotein A (gram/liter) is a component of the lipid profile which is a panel of blood tests used to find abnormalities in lipids. Ratio to baseline in Lipoprotein A was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement. | Baseline and day 85 |
| Ratio to Baseline in Lipoprotein A at Day 169 | Lipoprotein A (gram/liter) is a component of the lipid profile which is a panel of blood tests used to find abnormalities in lipids. Ratio to baseline in Lipoprotein A was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement. | Baseline and day 169 |
| Percent Change From Baseline in Weight | Change from baseline in weight was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the percent change from baseline indicates improvement. | Baseline and days 14, 29, 57, 85, 113, 141 and 169 |
| Percent Change From Baseline in Body Mass Index (BMI) | BMI was determined by height and weight measurements: Body weight (kg)/ [Height (m)]^2. Change from baseline in BMI was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the percent change from baseline indicates improvement. | Baseline and days 14, 29, 57, 85, 113, 141 and 169 |
| Change From Baseline in Waist-to-hip Ratio | Waist-to-hip ratio was derived using waist circumference and hip circumference, which was measured at the greatest protrusion of the buttocks. Change from baseline in waist-to-hip ratio was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the change from baseline indicates improvement. | Baseline and days 14, 29, 57, 85, 113, 141 and 169 |
| Albany |
| New York |
| 12206 |
| United States |
| Novartis Investigative Site | Norman | Oklahoma | 73069 | United States |
| Novartis Investigative Site | El Paso | Texas | 79935 | United States |
| Novartis Investigative Site | Sugar Land | Texas | 77479 | United States |
| Novartis Investigative Site | CABA | Buenos Aires | 1407 | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1056ABJ | Argentina |
| Novartis Investigative Site | Buenos Aires | C1120AAC | Argentina |
| Novartis Investigative Site | Prague | 12808 | Czechia |
| Novartis Investigative Site | Essen | Nordrhine Westphalia | 45136 | Germany |
| Novartis Investigative Site | Berlin | 10787 | Germany |
| Novartis Investigative Site | Elsterwerda | 04910 | Germany |
| Novartis Investigative Site | Amman | 11941 | Jordan |
| Novartis Investigative Site | El Achrafiyé | Lebanon |
| Novartis Investigative Site | Saida | 652 | Lebanon |
| Novartis Investigative Site | Istanbul | TUR | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Kocaeli | 41380 | Turkey (Türkiye) |
| Novartis Investigative Site | Talas / Kayseri | 38039 | Turkey (Türkiye) |
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| Pharmacokinetics (PK) Analysis Set | All randomized participants with at least one valid PK concentration measurement, who received LMB763 and no protocol deviations with relevant impact on PK data. |
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| Pharmacodynamics (PD) Analysis Set | All randomized participants with no protocol deviations with relevant impact on PD data. |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LMB763 | 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC. |
| BG001 | Placebo | Placebo was orally administered once daily for 24 weeks in addition to SoC. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) | UACR is a ratio between albumin and creatinine, and it estimates 24-hour urine albumin excretion. UACR (mg/mmol) = urine albumin [mg/L] / urine creatinine [mmol/L]. UACR was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement. | All randomized participants. At each time point, only participants with a value at both baseline and that time point were included. | Posted | Least Squares Mean | 80% Confidence Interval | Ratio to baseline | Baseline and days 14, 29, 57, 85, 113, 141 and 169 |
|
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| ||||||||||||||||||||||||||||
| Primary | Ratio to Baseline in 24 Hour Urinary Albumin at Week 24 (Day 169) | Albuminuria describes the existence of albumin in the urine and the gold-standard to assess albuminuria is 24-hour urinary albumin excretion (milligram/24 hours). An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline 24-hour urinary albumin excretion. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement. | Pharmacodynamics (PD) analysis set. Only participants with a value at both baseline and at Day 169 were included. | Posted | Least Squares Mean | 80% Confidence Interval | Ratio to baseline | Baseline and day 169 |
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| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The category Number of participants with AEs includes also the number of participants with SAEs. The number of participants in each category is reported in the table. | All randomized participants | Posted | Count of Participants | Participants | From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR) | Estimate Glomerular Filtration Rate (GFR) calculates estimated GFR (eGFR) from serum creatinine levels to assess kidney function. eGFR (milliliter/minute) was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A higher score in the ratio to baseline indicates improvement. | Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included. | Posted | Least Squares Mean | 80% Confidence Interval | Ratio | Baseline and days 14, 29, 57, 85, 113, 141 and 169 |
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| Secondary | Maximum Peak Observed Concentration (Cmax) of LMB763 | Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Cmax was determined using non-compartmental methods. No methods for imputation of missing data were used. | Pharmacokinetics (PK) analysis set | Posted | Mean | Standard Deviation | Nanogram/milliliter | pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14 |
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| Secondary | Time to Reach Maximum Blood Concentrations (Tmax) of LMB763 | Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Tmax was determined using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment). No methods for imputation of missing data were used. | Pharmacokinetics (PK) analysis set | Posted | Median | Full Range | Hour | pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14 |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Blood Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of LMB763 | Pharmacokinetic (PK) parameters were calculated based on LMB763 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUClast was determined using non-compartmental methods. No methods for imputation of missing data were used. | Pharmacokinetics (PK) analysis set | Posted | Mean | Standard Deviation | Hour*nanogram/milliliter | pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14 |
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| Secondary | Ratio to Baseline in Free Water Clearance | The free water clearance (mL/min) was calculated using the following formula: (Total Volume (mL) / Elapsed Date & Time (min)) * (1-24 hr Urine Osmolality (mOsmol/kg)/ Serum Osmolality (mOsmol/kg)) The result of free water clearance was rounded to one decimal place prior to statistical analysis. An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline free water clearance. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A higher score in the ratio to baseline indicates improvement. | Pharmacodynamics (PD) analysis set. Only participants with a value at both baseline and at Day 169 were included. | Posted | Least Squares Mean | 80% Confidence Interval | Ratio | Baseline and day 169 |
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| Secondary | Ratio to Baseline in Lipoprotein A at Day 85 | Lipoprotein A (gram/liter) is a component of the lipid profile which is a panel of blood tests used to find abnormalities in lipids. Ratio to baseline in Lipoprotein A was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement. | Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included. | Posted | Least Squares Mean | 80% Confidence Interval | Ratio | Baseline and day 85 |
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| Secondary | Ratio to Baseline in Lipoprotein A at Day 169 | Lipoprotein A (gram/liter) is a component of the lipid profile which is a panel of blood tests used to find abnormalities in lipids. Ratio to baseline in Lipoprotein A was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement. | Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included. | Posted | Least Squares Mean | 80% Confidence Interval | Ratio to baseline | Baseline and day 169 |
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| Secondary | Percent Change From Baseline in Weight | Change from baseline in weight was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the percent change from baseline indicates improvement. | Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included. | Posted | Least Squares Mean | 80% Confidence Interval | Percent change | Baseline and days 14, 29, 57, 85, 113, 141 and 169 |
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| Secondary | Percent Change From Baseline in Body Mass Index (BMI) | BMI was determined by height and weight measurements: Body weight (kg)/ [Height (m)]^2. Change from baseline in BMI was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the percent change from baseline indicates improvement. | Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included. | Posted | Least Squares Mean | 80% Confidence Interval | Percent change | Baseline and days 14, 29, 57, 85, 113, 141 and 169 |
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| Secondary | Change From Baseline in Waist-to-hip Ratio | Waist-to-hip ratio was derived using waist circumference and hip circumference, which was measured at the greatest protrusion of the buttocks. Change from baseline in waist-to-hip ratio was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A negative score in the change from baseline indicates improvement. | Pharmacodynamics (PD) analysis set. At each time point, only participants with a value at both baseline and that time point were included. | Posted | Least Squares Mean | 80% Confidence Interval | Ratio | Baseline and days 14, 29, 57, 85, 113, 141 and 169 |
|
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Adverse events were reported from the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days
Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
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 | LMB763 | 50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC. | 0 | 41 | 2 | 41 | 28 | 41 |
| EG001 | Placebo | Placebo was orally administered once daily for 24 weeks in addition to SoC. | 0 | 42 | 2 | 42 | 23 | 42 |
| EG002 | Total | Total | 0 | 83 | 4 | 83 | 51 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erysipelas | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Adenoviral conjunctivitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Ultrasound scan abnormal | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Urine albumin/creatinine ratio increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cerebral artery stenosis | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pruritus genital | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2021 | Apr 27, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Day 29 |
|
|
| Day 57 |
|
|
| Day 85 |
|
|
| Day 113 |
|
|
| Day 141 |
|
|
| Day 169 |
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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|
|
|
|
|
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|
| Participants |
|
|