A Study to Examine the Effects of the Leptin Receptor (LE... | NCT05088460 | Trialant
NCT05088460
Sponsor
Regeneron Pharmaceuticals
Status
Terminated
Last Update Posted
Oct 16, 2025Actual
Enrollment
20Actual
Phase
Phase 2
Conditions
Familial Partial Lipodystrophy
Metabolic Abnormalities
Interventions
REGN4461
Matching Placebo
Countries
United States
France
Spain
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT05088460
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
R4461-PLD-20100
Secondary IDs
ID
Type
Description
Link
2021-000138-33
EudraCT Number
Brief Title
A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
Official Title
A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients With Familial Partial Lipodystrophy
Acronym
LEAP
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor Decision
Expanded Access Info
No
Start Date
Feb 28, 2022Actual
Primary Completion Date
Dec 13, 2023Actual
Completion Date
Apr 18, 2024Actual
First Submitted Date
Oct 12, 2021
First Submission Date that Met QC Criteria
Oct 12, 2021
First Posted Date
Oct 22, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Apr 16, 2025
Results First Submitted that Met QC Criteria
Jun 30, 2025
Results First Posted Date
Jul 2, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 4, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jul 2, 2025Actual
Last Update Submitted Date
Oct 8, 2025
Last Update Posted Date
Oct 16, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin <8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL
The primary objectives will be evaluated for patients in Cohort A only:
To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG
To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c)
The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B:
To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia
To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia
The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B:
To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis
To evaluate the effect of REGN4461 on hunger
To evaluate safety and tolerability of REGN4461
To characterize the concentration profile of REGN4461 over time
To assess immunogenicity to REGN4461
Detailed Description
Not provided
Conditions Module
Conditions
Familial Partial Lipodystrophy
Metabolic Abnormalities
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
20Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Study Arm 1
Experimental
Randomized to placebo for 12 weeks and then crossover to REGN4461 for 12 weeks
Drug: REGN4461
Drug: Matching Placebo
Study Arm 2
Experimental
Randomized to receive REGN4461 for 24 weeks
Drug: REGN4461
Interventions
Name
Type
Description
Arm Group Labels
Other Names
REGN4461
Drug
Intravenous (IV) infusion loading dose followed by subcutaneous (SC) injection weekly (QW).
Study Arm 1
Study Arm 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A)
Percentage change in fasting serum TG was reported for participants with elevated baseline fasting TG (> 200 mg/dL) and with baseline leptin < 8.0 ng/mL (Cohort A).
Baseline to week 12
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A)
Change in HbA1c was reported for participants with elevated baseline HbA1c (> 7.0%) and with baseline leptin < 8.0 ng/mL (Cohort A).
Baseline to week 12
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B)
Percent change in fasting serum TG was reported for participants with elevated baseline fasting TG (>200 mg/dL) in Cohort B and Cohorts A + B.
Baseline to week 12
Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
Fasting leptin level ≤20.0 ng/ml, as determined during the screening period
Presence of significant metabolic abnormalities related to glucose and triglycerides (TGs) as defined in the protocol
Stable body weight within the 3 months prior to screening (no gain or loss of >5% current weight)
Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Atkins, Paleo, Vegetarianism, Veganism)
No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol
Key Exclusion Criteria:
Treatment with metreleptin within 3 months of the screening visit
Patients with a diagnosis of generalized lipodystrophy
Patients with a diagnosis of acquired lipodystrophy
Pregnant or breastfeeding women
NOTE: Other protocol defined inclusion/exclusion criteria apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trial Management
Regeneron Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Excel Medical Clinical Trials - A Flourish Research Site
Boca Raton
Florida
33434
United States
References Module
Citations
Not provided
See Also Links
Label
URL
A Plain Language Summary is available on TrialSummaries.com
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification
Access Criteria
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
A total of 66 participants were screened, of whom 20 were randomized and received study treatment.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
Intravenous (IV) infusion loading dose followed by subcutaneous (SC) injection weekly (QW).
Study Arm 1
Change in HbA1c was reported for participants with elevated baseline HbA1c (>7.0%) in Cohort B and Cohorts A + B.
Baseline to week 12
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1)
Percent change in fasting serum TG was reported for participants in Study Arm 1.
Baseline, Week 12, Week 24
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2)
Percent change in fasting serum TG was reported for participants in Study Arm 2.
Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1)
Change from baseline in HbA1c was reported for participants in Study Arm 1.
Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2)
Change from baseline in HbA1c was reported for participants in Study Arm 2.
Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1)
Change from baseline in fasting glucose was reported for participants in Study Arm 1.
Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2)
Change from baseline in fasting glucose was reported for participants in Study Arm 2.
Baseline, Week 12, Week 24
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) (Study Arm 1)
Percent change from baseline in MRI-PDFF was reported for participants with baseline MRI-PDFF ≥8.5% in Study Arm 1.
Baseline, Week 12, Week 24
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat MRI-PDFF (Study Arm 2)
Percent change from baseline in MRI-PDFF was reported for participants with baseline liver fat MRI-PDFF ≥8.5% in Study Arm 2.
Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Highest Hunger Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The highest hunger score asked participants to rate their highest hunger that day on a scale from 0 to 4, with higher scores representing the higher perceived hunger. A negative change from baseline indicated a reduction in perceived hunger.
Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Lowest Hunger Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The lowest hunger score asked participants to rate their lowest hunger that day on a scale from 0 to 4, with higher scores indicating higher perceived hunger. A negative change from baseline score indicated a reduction in perceived lowest hunger.
Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Felt Hungry Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among participants with lipodystrophy. The felt hungry score asked how much time participants felt hunger that day on a scale from 0 to 4, with higher scores indicating more time feeling hungry. A negative change from baseline score indicated a reduction in time spent feeling hungry.
Baseline, Week 12, Week 24
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Fullness Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The fullness score asked participants to rate how often they felt full after eating that day on a scale from 0 to 4, with higher scores indicating higher feeling of fullness. A negative change from baseline indicated a reduced feeling of fullness.
Baseline, Week 12, Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Up to Day 169
Concentrations of REGN4461 in Serum
Weeks 0, 1, 2, 3, 4, 5, 6, 9, 12, 13, 14, 15, 16, 17, 18, 21, 28, 32 and 36. Weeks 0 and 12 collected pre- and post-dose. All other time points were only pre-dose.
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response
Up to Day 281
National Institute of Health
Bethesda
Maryland
20892
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
15213
United States
UT Southwestern Medical Center
Dallas
Texas
75390
United States
ICAN, Institute of Cardiometabolism and Nutrition
Paris
75013
France
Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo
Santiago de Compostela
Galicia
15706
Spain
Ege University Faculty of Medicine
Izmir
Bornova
35100
Turkey (Türkiye)
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
FG002
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
FG003
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
FG0006 subjects
FG0016 subjects
FG0024 subjects
FG0034 subjects
Completed Treatment During DBTP
Double-blind Treatment Period (DBTP)
FG0005 subjects1 participant prematurely discontinued before completing the DBTP at the request of the sponsor due to the early study termination.
FG0016 subjects
FG0024 subjects
FG0034 subjects
Completed Treatment During SBTP
Single-blind Treatment Period (SBTP)
FG0005 subjects
FG0015 subjects1 participant prematurely discontinued study treatment before completing SBTP at the request of the sponsor due to the early study termination.
FG0023 subjects1 participant completed the DBTP but was prematurely discontinued before entering the SBTP at the request of the sponsor due to the early study termination.
FG0034 subjects
COMPLETED
Completed study All 20 participants were considered to have completed the study, including the 3 participants who were discontinued at the request of the sponsor during treatment
FG0006 subjects
FG0016 subjects
FG0024 subjects
FG0034 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
The double-blind safety analysis set (DB SAF) included all randomized participants who received any study drug during the double-blind treatment period (DBTP).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
BG001
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
BG002
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
BG003
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0024
BG0034
BG00420
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.5± 16.79
BG00143.8± 13.47
BG00248.0± 11.97
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Fasting Triglycerides Serum Concentration
Geometric Mean
Full Range
milligrams per deciliter (mg/dL)
Title
Denominators
Categories
Title
Measurements
BG0001100.9(405 to 5681)
BG001737.8(308 to 2487)
BG002
Hemoglobin A1c (HbA1c)
Mean
Standard Deviation
percentage of glycated hemoglobin
Title
Denominators
Categories
Title
Measurements
BG0008.8± 1.62
BG0018.2± 1.76
BG002
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
Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A)
Percentage change in fasting serum TG was reported for participants with elevated baseline fasting TG (> 200 mg/dL) and with baseline leptin < 8.0 ng/mL (Cohort A).
The Full Analysis Set (FAS) included all randomized participants who received any study drug in the double-blind treatment period (DBTP) and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percent change
Baseline to week 12
ID
Title
Description
OG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
Units
Counts
Participants
OG0005
OG0016
Title
Denominators
Categories
Title
Measurements
OG000-11.30± 46.306
OG001-38.97± 16.998
Primary
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A)
Change in HbA1c was reported for participants with elevated baseline HbA1c (> 7.0%) and with baseline leptin < 8.0 ng/mL (Cohort A).
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percentage of glycated hemoglobin
Baseline to week 12
ID
Title
Description
OG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
Units
Counts
Participants
Secondary
Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B)
Percent change in fasting serum TG was reported for participants with elevated baseline fasting TG (>200 mg/dL) in Cohort B and Cohorts A + B.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percent change
Baseline to week 12
ID
Title
Description
OG000
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG002
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
OG003
Secondary
Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B)
Change in HbA1c was reported for participants with elevated baseline HbA1c (>7.0%) in Cohort B and Cohorts A + B.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
percentage of glycated hemoglobin
Baseline to week 12
ID
Title
Description
OG000
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG002
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
OG003
Secondary
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1)
Percent change in fasting serum TG was reported for participants in Study Arm 1.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG002
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
Secondary
Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2)
Percent change in fasting serum TG was reported for participants in Study Arm 2.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG001
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG002
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Secondary
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1)
Change from baseline in HbA1c was reported for participants in Study Arm 1.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
percentage of glycated hemoglobin
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG002
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
Secondary
Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2)
Change from baseline in HbA1c was reported for participants in Study Arm 2.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
percentage of glycated hemoglobin
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG001
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG002
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Secondary
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1)
Change from baseline in fasting glucose was reported for participants in Study Arm 1.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
milligrams per deciliter (mg/dL)
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG002
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
Secondary
Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2)
Change from baseline in fasting glucose was reported for participants in Study Arm 2.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
mg/dL
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG001
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG002
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Secondary
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) (Study Arm 1)
Percent change from baseline in MRI-PDFF was reported for participants with baseline MRI-PDFF ≥8.5% in Study Arm 1.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with baseline MRI-PDFF ≥8.5%, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG002
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
Secondary
Percent Change From Baseline to Weeks 12 and 24 in Liver Fat MRI-PDFF (Study Arm 2)
Percent change from baseline in MRI-PDFF was reported for participants with baseline liver fat MRI-PDFF ≥8.5% in Study Arm 2.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with baseline MRI-PDFF ≥8.5%, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG001
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG002
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Secondary
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Highest Hunger Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The highest hunger score asked participants to rate their highest hunger that day on a scale from 0 to 4, with higher scores representing the higher perceived hunger. A negative change from baseline indicated a reduction in perceived hunger.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG002
Secondary
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Lowest Hunger Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The lowest hunger score asked participants to rate their lowest hunger that day on a scale from 0 to 4, with higher scores indicating higher perceived hunger. A negative change from baseline score indicated a reduction in perceived lowest hunger.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG002
Secondary
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Felt Hungry Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among participants with lipodystrophy. The felt hungry score asked how much time participants felt hunger that day on a scale from 0 to 4, with higher scores indicating more time feeling hungry. A negative change from baseline score indicated a reduction in time spent feeling hungry.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG002
Secondary
Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Fullness Score
The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The fullness score asked participants to rate how often they felt full after eating that day on a scale from 0 to 4, with higher scores indicating higher feeling of fullness. A negative change from baseline indicated a reduced feeling of fullness.
The FAS included all randomized participants who received any study drug in the DBTP and had at least 1 post-baseline assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG001
Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG002
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
The DB SAF included all participants who received any double-blind study drug in DBTP. The single-blind safety analysis set (SB SAF) included all randomized participants who received any single-blind study drug in the single-blind treatment period (SBTP).
Posted
Count of Participants
Participants
Up to Day 169
ID
Title
Description
OG000
DBTP Arm 1 Cohort A: Placebo
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.
OG001
DBTP Arm 2 Cohort A: REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.
OG002
DBTP Arm 1 Cohort B: Placebo
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.
OG003
DBTP Arm 2 Cohort B: REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.
Secondary
Concentrations of REGN4461 in Serum
The PK analysis set was defined as all randomized participants who received any study drug and have at least 1 non-missing measurement of REGN4461 concentration following the first dose of study drug. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluated at each time point.
Posted
Mean
Standard Deviation
milligrams per liter (mg/L)
Weeks 0, 1, 2, 3, 4, 5, 6, 9, 12, 13, 14, 15, 16, 17, 18, 21, 28, 32 and 36. Weeks 0 and 12 collected pre- and post-dose. All other time points were only pre-dose.
ID
Title
Description
OG000
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
OG001
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Units
Counts
Participants
OG000
Secondary
Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response
The ADA analysis set included all treated participants who received any amount of study drug and had at least one non-missing anti-drug antibody result following the first dose of study drug.
Posted
Count of Participants
Participants
Up to Day 281
ID
Title
Description
OG000
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
OG001
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Units
Counts
Participants
OG000
Time Frame
From signing of informed consent up to day 281 (end of study)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DBTP Arm 1 Cohort A: Placebo
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.
0
6
1
6
6
6
EG001
DBTP Arm 2 Cohort A: REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.
0
6
1
6
6
6
EG002
DBTP Arm 1 Cohort B: Placebo
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP.
0
4
1
4
4
4
EG003
DBTP Arm 2 Cohort B: REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP.
0
4
0
4
4
4
EG004
SBTP Arm 1 Cohort A: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
0
5
1
5
3
5
EG005
SBTP Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
0
6
1
6
5
6
EG006
SBTP Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
0
3
0
3
3
3
EG007
SBTP Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
0
4
0
4
4
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pancreatitis acute
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected4 at risk
Angina pectoris
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Influenza
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0002 events2 affected6 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected4 at risk
Bacterial infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
COVID-19
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0003 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Fungal infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Otitis externa
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Otitis media
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Paronychia
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected6 at risk
EG0022 events2 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Gastrointestinal wall thickening
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Plicated tongue
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0004 events2 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Brain fog
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0023 events1 affected4 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Migraine
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Mononeuropathy
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Bipolar I disorder
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Poor quality sleep
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0015 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral swelling
General disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Asthenia
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Chest discomfort
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Infusion site extravasation
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Injection site reaction
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG00110 events2 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Arterial injury
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Blood pressure increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Carbohydrate antigen 19-9 increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Haematocrit increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hyperphagia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events2 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected4 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Defect conduction intraventricular
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Muscular dystrophy
Congenital, familial and genetic disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected4 at risk
EG003
Photophobia
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Vaginal cyst
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Snoring
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D008060
Lipodystrophy
D012875
Skin Diseases, Metabolic
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D008052
Lipid Metabolism, Inborn Errors
D052439
Lipid Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
40.3
± 12.82
BG00443.0± 13.40
3
BG0034
BG00418
Male
BG0001
BG0010
BG0021
BG0030
BG0042
0
BG0030
BG0040
Not Hispanic or Latino
BG0006
BG0016
BG0024
BG0034
BG00420
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
0
BG0030
BG0040
Asian
BG0000
BG0010
BG0020
BG0031
BG0041
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
White
BG0006
BG0016
BG0023
BG0033
BG00418
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG0041
675.0
(426 to 1534)
BG003336.2(150 to 1376)
BG004698.3(150 to 5681)
6.9
± 0.91
BG0038.6± 2.06
BG0048.2± 1.68
OG0004
OG0015
Title
Denominators
Categories
Title
Measurements
OG000-0.05± 0.451
OG001-1.08± 1.108
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Units
Counts
Participants
OG0004
OG0014
OG0029
OG00310
Title
Denominators
Categories
Title
Measurements
OG00036.78± 44.863
OG001-35.59± 8.754
OG00210.07± 49.689
OG003-37.62± 13.752
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Units
Counts
Participants
OG0002
OG0013
OG0026
OG0038
Title
Denominators
Categories
Title
Measurements
OG000-0.20± 0.283
OG001-0.90± 0.964
OG002-0.10± 0.379
OG003-1.01± 0.988
Units
Counts
Participants
OG0005
OG0014
OG0029
Title
Denominators
Categories
Week 12
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
Title
Measurements
OG000-11.30± 46.306
OG00136.78± 44.863
OG00210.07± 49.689
Week 24
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0027
Title
Measurements
OG000
Units
Counts
Participants
OG0006
OG0014
OG00210
Title
Denominators
Categories
Week 12
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG00210
Title
Measurements
OG000-38.97± 16.998
OG001-35.59± 8.754
OG002-37.62± 13.752
Week 24
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0028
Title
Measurements
OG000
Units
Counts
Participants
OG0005
OG0014
OG0029
Title
Denominators
Categories
Week 12
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
Title
Measurements
OG000-0.10± 0.406
OG0010.13± 0.427
OG0020.00± 0.406
Week 24
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0028
Title
Measurements
OG000
Units
Counts
Participants
OG0006
OG0014
OG00210
Title
Denominators
Categories
Week 12
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG00210
Title
Measurements
OG000-0.92± 1.068
OG001-0.78± 0.826
OG002-0.86± 0.931
Week 24
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
Title
Measurements
OG000
Units
Counts
Participants
OG0005
OG0014
OG0029
Title
Denominators
Categories
Week 12
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
Title
Measurements
OG0004.8± 29.55
OG0010.0± 60.37
OG0022.7± 42.54
Week 24
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0027
Title
Measurements
OG000
Units
Counts
Participants
OG0006
OG0014
OG00210
Title
Denominators
Categories
Week 12
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG00210
Title
Measurements
OG000-5.2± 36.55
OG001-19.5± 22.87
OG002-10.9± 31.17
Week 24
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0028
Title
Measurements
OG000
Units
Counts
Participants
OG0003
OG0012
OG0025
Title
Denominators
Categories
Week 12
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0025
Title
Measurements
OG000-11.44± 18.576
OG001-0.74± 9.919
OG002-7.16± 15.214
Week 24
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
Title
Measurements
OG000
Units
Counts
Participants
OG0004
OG0014
OG0028
Title
Denominators
Categories
Week 12
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0028
Title
Measurements
OG000-17.05± 25.788
OG001-18.80± 17.300
OG002-17.92± 20.351
Week 24
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0027
Title
Measurements
OG000
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG003
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG004
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
OG005
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Units
Counts
Participants
OG0006
OG0016
OG0024
OG0034
OG00410
OG00510
Title
Denominators
Categories
Week 12
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG000-0.060± 0.9009
OG001-0.538± 0.4679
OG002-0.240± 0.2483
OG003
Week 24
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG003
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG004
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
OG005
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Units
Counts
Participants
OG0006
OG0016
OG0024
OG0034
OG00410
OG00510
Title
Denominators
Categories
Week 12
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0000.185± 0.8013
OG001-0.475± 0.4630
OG002-0.338± 0.4287
OG003
Week 24
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG003
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG004
Arm 1 Combined Cohort A + B: Placebo to REGN4461
"Arm 1 Cohort A" and "Arm 1 Cohort B" combined
OG005
Arm 2 Combined Cohort A + B: REGN4461 to REGN4461
"Arm 2 Cohort A" and "Arm 2 Cohort B" combined
Units
Counts
Participants
OG0006
OG0016
OG0024
OG0034
OG00410
OG00510
Title
Denominators
Categories
Week 12
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0000.248± 0.8642
OG001-0.550± 0.5334
OG002-0.168± 0.2900
OG003
Week 24
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG003
Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG007
SBTP Arm 2 Cohort A: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG008
SBTP Arm 1 Cohort B: Placebo to REGN4461
Participants randomized to Arm 1 received placebo for 12 weeks during the DBTP followed by crossover to REGN4461 treatment for 12 weeks during the SBTP.
OG009
SBTP Arm 2 Cohort B: REGN4461 to REGN4461
Participants randomized to Arm 2 received REGN4461 treatment for 12 weeks during the DBTP followed by an additional 12 weeks of REGN4461 treatment during the SBTP.
OG010
SBTP Arm 1 Combined Cohort A + B: Placebo to REGN4461