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Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) (ENLIVEN)

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIO89-100
Sponsored by
89bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis focused on measuring Liver Diseases, Fatty Liver, Digestive System Diseases, Non-alcoholic Fatty Liver Disease, Metabolic diseases, NASH NAFLD

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Age 21 to 75

  • Biopsy-confirmed NASH with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation.

    • Qualifying biopsy must be either within 6 months of screening visit or obtained during screening period

Key Exclusion Criteria:

  • Have poorly controlled high blood pressure
  • Have type 1 diabetes or poorly controlled type 2 diabetes.
  • History of cirrhosis or evidence of cirrhosis by clinical, imaging or liver biopsy evaluation
  • Are planning to try to lose weight during the conduct of the study.
  • Have a BMI <25 kg/m2

Other inclusion and exclusion criteria may apply.

Sites / Locations

  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site
  • 89bio Clinical Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

BIO89-100 - 15 mg QW

Experimental: BIO89-100 - 30 mg QW

Experimental: BIO89-100 - 44 mg Q2W

Placebo Comparator: Placebo QW

Placebo Comparator: Placebo Q2W

Arm Description

Outcomes

Primary Outcome Measures

Main: Proportion of participants with histological resolution of NASH without worsening of fibrosis
Main: Proportion of participants with ≥1 stage decrease in fibrosis stage with no worsening of NASH

Secondary Outcome Measures

Main: Proportion of participants with at least a 2-point improvement in NAS and no worsening of fibrosis
Main: Proportion of participants with NASH resolution AND with ≥1 stage decrease in fibrosis stage
Main: Proportion of participants with at least a 2-point improvement in NAS and are MRI-PDFF responders AND ALT responders
Main: Absolute and percentage change from baseline in serum triglycerides
Main: Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol
Main: Absolute change and percentage change from baseline in Alanine Transaminase (ALT)
Main: Absolute change and percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3)
Main: Absolute change and percentage change from baseline in Magnetic Resonance Imaging - Hepatic Fat Fraction (MRI-PDFF)
Main: Percentage change from baseline in HbA1c
Main: Absolute and percentage change from baseline in Adiponectin
Main: Steady-state blood level of BIO89-100
Plasma trough concentration (ng/mL) of BIO89-100 taken at pre-dose samples
Main: Absolute and percentage change from baseline in Non High Density Lipoprotein (HDL) Cholesterol
Main: Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol

Full Information

First Posted
June 10, 2021
Last Updated
July 21, 2023
Sponsor
89bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04929483
Brief Title
Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
Acronym
ENLIVEN
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BIO89-100 in Subjects With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
89bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
Keywords
Liver Diseases, Fatty Liver, Digestive System Diseases, Non-alcoholic Fatty Liver Disease, Metabolic diseases, NASH NAFLD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIO89-100 - 15 mg QW
Arm Type
Experimental
Arm Title
Experimental: BIO89-100 - 30 mg QW
Arm Type
Experimental
Arm Title
Experimental: BIO89-100 - 44 mg Q2W
Arm Type
Experimental
Arm Title
Placebo Comparator: Placebo QW
Arm Type
Placebo Comparator
Arm Title
Placebo Comparator: Placebo Q2W
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BIO89-100
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Main: Proportion of participants with histological resolution of NASH without worsening of fibrosis
Time Frame
24 Weeks
Title
Main: Proportion of participants with ≥1 stage decrease in fibrosis stage with no worsening of NASH
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Main: Proportion of participants with at least a 2-point improvement in NAS and no worsening of fibrosis
Time Frame
24 Weeks
Title
Main: Proportion of participants with NASH resolution AND with ≥1 stage decrease in fibrosis stage
Time Frame
24 Weeks
Title
Main: Proportion of participants with at least a 2-point improvement in NAS and are MRI-PDFF responders AND ALT responders
Time Frame
24 Weeks
Title
Main: Absolute and percentage change from baseline in serum triglycerides
Time Frame
12 Weeks, 24 Weeks
Title
Main: Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol
Time Frame
12 Weeks, 24 Weeks
Title
Main: Absolute change and percentage change from baseline in Alanine Transaminase (ALT)
Time Frame
12 Weeks, 24 Weeks, 48 Weeks
Title
Main: Absolute change and percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3)
Time Frame
12 Weeks, 24 Weeks, 48 Weeks
Title
Main: Absolute change and percentage change from baseline in Magnetic Resonance Imaging - Hepatic Fat Fraction (MRI-PDFF)
Time Frame
12 Weeks, 24 Weeks, 48 Weeks
Title
Main: Percentage change from baseline in HbA1c
Time Frame
12 Weeks, 24 Weeks
Title
Main: Absolute and percentage change from baseline in Adiponectin
Time Frame
12 Weeks, 24 Weeks
Title
Main: Steady-state blood level of BIO89-100
Description
Plasma trough concentration (ng/mL) of BIO89-100 taken at pre-dose samples
Time Frame
Blood samples for PK analysis collected at up to 8 study visits over the course of approximately 48 weeks
Title
Main: Absolute and percentage change from baseline in Non High Density Lipoprotein (HDL) Cholesterol
Time Frame
12 Weeks, 24 Weeks
Title
Main: Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol
Time Frame
12 Weeks, 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Age 21 to 75 Biopsy-confirmed NASH with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. Qualifying biopsy must be either within 6 months of screening visit or obtained during screening period Key Exclusion Criteria: Have poorly controlled high blood pressure Have type 1 diabetes or poorly controlled type 2 diabetes. History of cirrhosis or evidence of cirrhosis by clinical, imaging or liver biopsy evaluation Are planning to try to lose weight during the conduct of the study. Have a BMI <25 kg/m2 Other inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Millie Gottwald, PharmD
Organizational Affiliation
89bio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
89bio Clinical Study Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
89bio Clinical Study Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
89bio Clinical Study Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
89bio Clinical Study Site
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
89bio Clinical Study Site
City
Madison
State/Province
Alabama
ZIP/Postal Code
35758
Country
United States
Facility Name
89bio Clinical Study Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
89bio Clinical Study Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85036
Country
United States
Facility Name
89bio Clinical Study Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
89bio Clinical Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712-4044
Country
United States
Facility Name
89bio Clinical Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712-4046
Country
United States
Facility Name
89bio Clinical Study Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
89bio Clinical Study Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-6414
Country
United States
Facility Name
89bio Clinical Study Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
89bio Clinical Study Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
89bio Clinical Study Site
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
89bio Clinical Study Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
89bio Clinical Study Site
City
Orange
State/Province
California
ZIP/Postal Code
92866
Country
United States
Facility Name
89bio Clinical Study Site
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
89bio Clinical Study Site
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
89bio Clinical Study Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
89bio Clinical Study Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
89bio Clinical Study Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
89bio Clinical Study Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
89bio Clinical Study Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
89bio Clinical Study Site
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
89bio Clinical Study Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
89bio Clinical Study Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
89bio Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
89bio Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
89bio Clinical Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
89bio Clinical Study Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
89bio Clinical Study Site
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
89bio Clinical Study Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
89bio Clinical Study Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
89bio Clinical Study Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Facility Name
89bio Clinical Study Site
City
Viera
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
Facility Name
89bio Clinical Study Site
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
89bio Clinical Study Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
89bio Clinical Study Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
89bio Clinical Study Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Facility Name
89bio Clinical Study Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States
Facility Name
89bio Clinical Study Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
89bio Clinical Study Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072-3151
Country
United States
Facility Name
89bio Clinical Study Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072-3155
Country
United States
Facility Name
89bio Clinical Study Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
89bio Clinical Study Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
89bio Clinical Study Site
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
89bio Clinical Study Site
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
89bio Clinical Study Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63033
Country
United States
Facility Name
89bio Clinical Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
89bio Clinical Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
89bio Clinical Study Site
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
89bio Clinical Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Facility Name
89bio Clinical Study Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28027
Country
United States
Facility Name
89bio Clinical Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
89bio Clinical Study Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
89bio Clinical Study Site
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Facility Name
89bio Clinical Study Site
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
89bio Clinical Study Site
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
89bio Clinical Study Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
89bio Clinical Study Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
89bio Clinical Study Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
89bio Clinical Study Site
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
89bio Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78757-8051
Country
United States
Facility Name
89bio Clinical Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78757-8059
Country
United States
Facility Name
89bio Clinical Study Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
89bio Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
89bio Clinical Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
89bio Clinical Study Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
89bio Clinical Study Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
89bio Clinical Study Site
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
89bio Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
89bio Clinical Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
89bio Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
89bio Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
89bio Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4801
Country
United States
Facility Name
89bio Clinical Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-5069
Country
United States
Facility Name
89bio Clinical Study Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
89bio Clinical Study Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
89bio Clinical Study Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
89bio Clinical Study Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
89bio Clinical Study Site
City
Sandy
State/Province
Utah
ZIP/Postal Code
84092
Country
United States
Facility Name
89bio Clinical Study Site
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
89bio Clinical Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
89bio Clinical Study Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
89bio Clinical Study Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
89bio Clinical Study Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
89bio Clinical Study Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
89bio Clinical Study Site
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)

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