Trial Outcomes & Findings for Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease (NCT NCT02217345)

NCT ID: NCT02217345

Last Updated: 2022-11-22

Results Overview

Change in Intrahepatic lipid content by 1H-MRS over 6 months in the GH vs placebo group

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 131 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2022-11-22

Participant Flow

Subjects were recruited through hospital-wide and community advertisements between 2017-2021. Recruitment techniques included posting advertisements on the internet (i.e. Craigslist and Facebook) and on the Massachusetts General Hospital's clinical trial recruitment website.

Of the 131 people who signed a consent form, 78 were unable to participate due to various reasons including meeting ineligibility criteria. The 53 subjects who remained were randomized to one of two arms. One subject discontinued after randomization but before any baseline procedures were completed, leaving 52 subjects with available baseline data.

Participant milestones

Measure	Growth Hormone Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	Placebo Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
Overall Study STARTED	27	26
Overall Study Baseline Data Available	26	26
Overall Study COMPLETED	20	21
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Measure	Growth Hormone Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	Placebo Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	3	2
Overall Study Adverse Event	2	1
Overall Study Physician Decision	0	1

Baseline Characteristics

Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease

Baseline characteristics by cohort

Measure	Growth Hormone n=26 Participants Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	Placebo n=26 Participants Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 12 • n=5 Participants	46 years STANDARD_DEVIATION 12 • n=7 Participants	46 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	26 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Change in Intrahepatic lipid content by 1H-MRS over 6 months in the GH vs placebo group

Outcome measures

Measure	Growth Hormone n=20 Participants Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	Placebo n=21 Participants Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
Change in Intrahepatic Lipid Content Between Baseline and 6 Months as Measured by 1H-magnetic Resonance Spectroscopy (1H-MRS). Endpoints Were Assessed at Baseline and 6 Months.	-5.2 percent liver fat Standard Deviation 10.5	3.8 percent liver fat Standard Deviation 6.9

SECONDARY outcome

Timeframe: 6 months

Change in serum high sensitivity C-reactive protein (hsCRP) (mg/L) between baseline and 6 months.

Outcome measures

Measure	Growth Hormone n=20 Participants Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	Placebo n=21 Participants Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
Change in Serum High Sensitivity C-reactive Protein (hsCRP) Between Baseline and 6 Months.	-0.8 mg/L Standard Deviation 0.9	0.3 mg/L Standard Deviation 1.7

Adverse Events

Growth Hormone

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Growth Hormone n=24 participants at risk Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	Placebo n=25 participants at risk Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
Surgical and medical procedures Unrelated surgical procedure	4.2% 1/24 • Number of events 1 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.	0.00% 0/25 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.

Other adverse events

Measure	Growth Hormone n=24 participants at risk Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered for 6 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	Placebo n=25 participants at risk Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self-administered sub-cutaneous daily for 6 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
Blood and lymphatic system disorders Edema	20.8% 5/24 • Number of events 5 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.	0.00% 0/25 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.
General disorders Headache	12.5% 3/24 • Number of events 3 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.	16.0% 4/25 • Number of events 4 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.
Musculoskeletal and connective tissue disorders Carpal Tunnel Syndrome	0.00% 0/24 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.	4.0% 1/25 • Number of events 1 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.
Musculoskeletal and connective tissue disorders Joint Pain or Stiffness	16.7% 4/24 • Number of events 4 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.	24.0% 6/25 • Number of events 6 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 3/24 • Number of events 3 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.	8.0% 2/25 • Number of events 2 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.
Nervous system disorders Numbness or tingling	12.5% 3/24 • Number of events 3 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.	8.0% 2/25 • Number of events 2 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.
Skin and subcutaneous tissue disorders Injection site discomfort or bruising	16.7% 4/24 • Number of events 4 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.	20.0% 5/25 • Number of events 5 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.
Immune system disorders Allergic Reaction	4.2% 1/24 • Number of events 1 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.	0.00% 0/25 • 6 months GH is FDA approved. Adverse events were defined by the clinicaltrials.gov definitions and categorized as "expected" and "unexpected" based on the medication package insert. GH group: 27 randomized and 3 pre-drug discontinuations = 24 at risk Placebo group: 26 randomized and 1 pre-drug discontinuation = 25 at risk \# of events = # of subjects that experienced the side effect at any point during the study.

Additional Information

Dr. Karen K. Miller

Massachusetts General Hospital

Phone: 617-726-3870

Email: kkmiller@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place