Trial Outcomes & Findings for Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease (NCT NCT03459079)
NCT ID: NCT03459079
Last Updated: 2024-09-19
Results Overview
Changes from baseline (Adjusted LS means) in absolute percent for change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (¹H-MRS)are reported in each arms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
128 participants
Primary outcome timeframe
24 weeks of treatment
Results posted on
2024-09-19
Participant Flow
Of 128 total enrolled participants, 38 subjects with type 2 diabetes met inclusion criteria and were randomized to be treated. 10 healthy controls met inclusion criteria and completed imaging and other study assessments. This study was performed during the epidemic of COVID that greatly impacted recruitment and promoted dropout.
Participant milestones
| Measure |
Lanifibranor Arm
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
Healthy Control Group (Not a Treatment Arm)
This group ONLY underwent baseline labs, baseline liver fat assessment and one insulin sensitivity measurement to establish the "normal" for these parameters and to which compare the 2 treatment arms (i.e., lanifibranor and placebo arms). They are NOT treatment arms and participation ended after qualifying and the above studies.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
10
|
|
Overall Study
COMPLETED
|
14
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
0
|
Reasons for withdrawal
| Measure |
Lanifibranor Arm
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
Healthy Control Group (Not a Treatment Arm)
This group ONLY underwent baseline labs, baseline liver fat assessment and one insulin sensitivity measurement to establish the "normal" for these parameters and to which compare the 2 treatment arms (i.e., lanifibranor and placebo arms). They are NOT treatment arms and participation ended after qualifying and the above studies.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
Baseline Characteristics
Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease
Baseline characteristics by cohort
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
Healthy Control Group (Not a Treatment Arm)
n=10 Participants
This group ONLY underwent baseline labs, baseline liver fat assessment and one insulin sensitivity measurement to establish the "normal" for these parameters and to which compare the 2 treatment arms (i.e., lanifibranor and placebo arms). They are NOT treatment arms and participation ended after qualifying and the above studies.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 7 • n=5 Participants
|
58 years
STANDARD_DEVIATION 11 • n=7 Participants
|
43 years
STANDARD_DEVIATION 18 • n=5 Participants
|
60 years
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
10 participants
n=5 Participants
|
48 participants
n=4 Participants
|
|
Intrahepatic triglyceride content
|
21 %
STANDARD_DEVIATION 7 • n=5 Participants
|
18 %
STANDARD_DEVIATION 7 • n=7 Participants
|
3 %
STANDARD_DEVIATION 1 • n=5 Participants
|
19.5 %
STANDARD_DEVIATION 7.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeks of treatmentPopulation: We report absolute change from baseline in LS mean \[95% CI\]
Changes from baseline (Adjusted LS means) in absolute percent for change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (¹H-MRS)are reported in each arms.
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Change in Intrahepatic Triglycerides (IHTG) Quantified by Proton Magnetic Resonance and Spectroscopy (¹H-MRS)
|
-8.7 percentage decrease from baseline
Interval -11.3 to -6.0
|
-3.0 percentage decrease from baseline
Interval -5.9 to -0.2
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Population: ≥30% reduction in IHTG
Percentage of patients with a decrease from baseline in IHTG (quantified by ¹H-MRS) to week 24 of ≥ 30% in each group.
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Percentage of Patients With a Decrease From Baseline in IHTG (Quantified by ¹H-MRS) to Week 24 of ≥ 30%.
|
65 percentage of participants
Interval 41.0 to 85.0
|
22 percentage of participants
Interval 6.0 to 48.0
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Population: Full Analyses Set
Percentage of patients with NAFLD resolution, defined as having ≤ 5.5% IHTG (quantified by 1H- MRS) in both arms.
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Percentage of Patients With NAFLD Resolution, Defined as Having ≤ 5.5% IHTG (Quantified by 1H- MRS).
|
25 percentage of participants
Interval 9.0 to 49.0
|
0 percentage of participants
Interval 0.0 to 19.0
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Population: Full Analyses Set
Changes from baseline in hepatic insulin sensitivity (Hepatic Insulin Resistance Index) as a relative percent change is presented (i.e. \[24 week result- baseline result\]/baseline result \*100).
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Improvement in Hepatic Insulin Sensitivity (Hepatic Insulin Resistance Index Reported as Relative Percent Change)
|
-26 percentage of baseline value
Interval -37.0 to -14.0
|
-7 percentage of baseline value
Interval -19.0 to 4.0
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Population: Full analysis set
Changes from baseline in absolute value of adipose tissue insulin resistance (ADIPO-IR) index will be compared between both arms. This is calculated using the formula below: Adipo-IR index = fasting serum free fatty acid concentration x fasting plasma insulin level. A higher value indicated higher insulin resistance.
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Improvement in Adipose Tissue Insulin Sensitivity.
|
-2.7 index
Interval -4.3 to -1.2
|
-0.7 index
Interval -2.4 to 0.9
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Population: Full analysis set
Relative percent changes from baseline in insulin-stimulated muscle glucose disposal (%) will be compared between both arms (i.e. \[24 week result- baseline result\]/baseline result \*100).
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Improvement in Muscle Insulin Sensitivity (Rd).
|
30 percentage change from baseline
Interval 13.0 to 46.0
|
0 percentage change from baseline
Interval -17.0 to 18.0
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Population: Full analysis set
Absolute changes from baseline will be compared between both arms (i.e., percentage at 24 weeks subtracted from the percentage at baseline).
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Absolute Change in Glycemic Control (Hemoglobin A1c).
|
-0.7 absolute percent change from baseline
Interval -1.0 to -0.5
|
-0.1 absolute percent change from baseline
Interval -0.3 to 0.2
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Population: Full analysis set
Changes from baseline will be compared between both arms.
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Change in Plasma HDL-C (mg/dl).
|
7.6 absolute change in mg/dl from baseline
Interval 4.4 to 10.7
|
0.9 absolute change in mg/dl from baseline
Interval -2.4 to 4.3
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Population: Full analysis set
Changes from baseline in liver stiffness measurement in kPa by vibration controlled transient elastography measured in both arms.
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Changes in Hepatic Fibrosis (Liver Stiffness Measurement by Vibration Controlled Transient Elastography in kPa) on Imaging.
|
-1.49 absolute change in kPa from baseline
Interval -2.66 to -0.31
|
-0.34 absolute change in kPa from baseline
Interval -1.57 to 0.9
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Population: Full analysis set
Absolute change (Mean ± SD) changes from baseline in plasma cytokeratin 18 (IU/L) levels in both arms.
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Change in Plasma Biomarkers of Liver Fibrosis (Plasma Cytokeratin 18 Measured in IU/L).
|
-130.71 absolute change in from baseline in IU/L
Standard Deviation 164.28
|
-70.21 absolute change in from baseline in IU/L
Standard Deviation 230.39
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Population: Two subjects in the lanifibranor group missing this measurement due to technical errors
Changes from baseline in liver stiffness measurement by magnetic resonance elastography is measured in both arms (absolute change in kPa from baseline).
Outcome measures
| Measure |
Lanifibranor Arm
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Changes in Hepatic Fibrosis (Liver Stiffness Measurement by Magnetic Resonance Elastography in kPa) on Imaging.
|
0.23 kPa
Interval 0.03 to 0.42
|
-0.06 kPa
Interval -0.25 to 0.13
|
SECONDARY outcome
Timeframe: Baseline measurement of liver stiffness by magnetic resonance elastography is reported in each arm.Population: Full analysis set
Baseline liver stiffness measurement (LSM) by magnetic resonance elastography (in kPa) in both arms.
Outcome measures
| Measure |
Lanifibranor Arm
n=20 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Lanifibranor: The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
|
Placebo
n=18 Participants
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Placebo: Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
|
|---|---|---|
|
Hepatic Fibrosis (Liver Stiffness Measurement by Magnetic Resonance Elastography) on Imaging.
|
2.8 kPa
Standard Deviation 0.8
|
2.5 kPa
Standard Deviation 1.1
|
Adverse Events
Lanifibranor Arm
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Healthy Control Group (Not a Treatment Arm)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lanifibranor Arm
n=20 participants at risk
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
|
Placebo
n=18 participants at risk
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
|
Healthy Control Group (Not a Treatment Arm)
n=10 participants at risk
This group ONLY underwent baseline labs, baseline liver fat assessment and one insulin sensitivity measurement to establish the "normal" for these parameters and to which compare the 2 treatment arms (i.e., lanifibranor and placebo arms). They are NOT treatment arms and participation ended after qualifying and the above studies.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 pneumonia and pulmonary embolism
|
5.0%
1/20 • Number of events 1 • 28 weeks
|
0.00%
0/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
Other adverse events
| Measure |
Lanifibranor Arm
n=20 participants at risk
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
|
Placebo
n=18 participants at risk
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
|
Healthy Control Group (Not a Treatment Arm)
n=10 participants at risk
This group ONLY underwent baseline labs, baseline liver fat assessment and one insulin sensitivity measurement to establish the "normal" for these parameters and to which compare the 2 treatment arms (i.e., lanifibranor and placebo arms). They are NOT treatment arms and participation ended after qualifying and the above studies.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
26.3%
5/19 • 28 weeks
|
16.7%
3/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Elevated lipase level
|
25.0%
5/20 • 28 weeks
|
16.7%
3/18 • 28 weeks
|
10.0%
1/10 • Number of events 1 • 28 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
4/20 • 28 weeks
|
11.1%
2/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.0%
3/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/20 • 28 weeks
|
16.7%
3/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatological
|
10.0%
2/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Renal and urinary disorders
Decrease in eGFR
|
5.0%
1/20 • 28 weeks
|
11.1%
2/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Hepatobiliary disorders
Transaminitis
|
5.0%
1/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Endocrine disorders
Hypoglycemia
|
5.0%
1/20 • 28 weeks
|
0.00%
0/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Cardiac disorders
Edema
|
5.0%
1/20 • 28 weeks
|
0.00%
0/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/20 • 28 weeks
|
11.1%
2/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • 28 weeks
|
0.00%
0/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
10.0%
2/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Upset stomach
|
10.0%
2/20 • 28 weeks
|
0.00%
0/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Increased appetite
|
5.0%
1/20 • 28 weeks
|
0.00%
0/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Orange stools
|
5.0%
1/20 • 28 weeks
|
0.00%
0/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Endocrine disorders
Abnormal thyroid test
|
5.0%
1/20 • 28 weeks
|
0.00%
0/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Renal and urinary disorders
Hyponatremia
|
0.00%
0/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Renal and urinary disorders
Hypokalemia
|
0.00%
0/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Endocrine disorders
Hypecalcemia
|
0.00%
0/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Renal and urinary disorders
Abnormal urinalysis
|
0.00%
0/20 • 28 weeks
|
11.1%
2/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Hepatobiliary disorders
Fluctuating lipase levels
|
10.0%
2/20 • 28 weeks
|
5.6%
1/18 • 28 weeks
|
0.00%
0/10 • 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Arm pain
|
0.00%
0/20 • 28 weeks
|
0.00%
0/18 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
|
Cardiac disorders
Vsasovagal reaction
|
0.00%
0/20 • 28 weeks
|
0.00%
0/18 • 28 weeks
|
10.0%
1/10 • 28 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place