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Trial record 18 of 21 for:    Tesamorelin OR Egrifta[TREATMENT] AND HIV [CONDITION]

Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese

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ClinicalTrials.gov Identifier: NCT00675506
Recruitment Status : Completed
First Posted : May 9, 2008
Results First Posted : January 7, 2013
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Abdominal Obesity
Growth Hormone Deficiency
Interventions Drug: Growth hormone releasing hormone (GHRH) 1-44
Drug: Placebo
Enrollment 60

Recruitment Details  
Pre-assignment Details  
Arm/Group Title TH9507 Placebo
Hide Arm/Group Description

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months

Participants received treatment with placebo medication.

Placebo : 2-mg sub-cutaneous abdominal injections once daily for 12 months

Period Title: Overall Study
Started 31 29
Received Intervention 29 [1] 29
Completed 19 17
Not Completed 12 12
Reason Not Completed
Lost to Follow-up             1             5
Lost interest             3             5
Elevated fasting glucose             2             1
Elevated IGF-1 prior to treatment             1             0
Elevated IGF-1             2             0
Hypersensitivity Reaction             1             0
Disclosed history of cancer             1             0
Declined participation             1             0
Schedule conflict             0             1
[1]
Two subjects did not start treatment: 1) disclosed cancer history, 2) declined participation.
Arm/Group Title TH9507 Placebo Total
Hide Arm/Group Description

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months

Participants received treatment with placebo medication.

Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months

Total of all reporting groups
Overall Number of Baseline Participants 31 29 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
31
 100.0%
29
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 29 participants 60 participants
42.5  (7.1) 39.9  (9.5) 41.2  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
Female
11
  35.5%
10
  34.5%
21
  35.0%
Male
20
  64.5%
19
  65.5%
39
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 29 participants 60 participants
31 29 60
1.Primary Outcome
Title Change in Visceral Adipose Tissue Volume
Hide Description Abdominal visceral adipose tissue and subcutaneous adipose tissue were assessed using a single crosssectional slice from noncontrast computed tomography at the L4 level. The change in abdominal visceral adiposity between baseline and twelve months is reported.
Time Frame Measured at baseline and Months 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.
Arm/Group Title TH9507 Placebo
Hide Arm/Group Description:

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months.

Participants received treatment with placebo medication.

Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months

Overall Number of Participants Analyzed 29 29
Mean (Standard Error)
Unit of Measure: cm2
-16  (9) 19  (9)
2.Secondary Outcome
Title Change in Carotid Intima-media Thickness
Hide Description Carotid intima media thickness imaging of the common carotid artery was conducted using a high-resolution 7.5-MHz phased-array transducer (SONOS 2000/2500. The change of the carotid intima media thickness measurement between baseline and 12 months is reported.
Time Frame Measured at baseline and Months 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.
Arm/Group Title TH9507 Placebo
Hide Arm/Group Description:

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months.

Participants received treatment with placebo medication.

Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months

Overall Number of Participants Analyzed 29 29
Mean (Standard Error)
Unit of Measure: mm
-0.03  (0.01) 0.01  (0.01)
3.Secondary Outcome
Title Change in Lipid Profile (Total Cholesterol, High-density Lipoproteins [HDL] Cholesterol, Low-density Lipoproteins [LDL] Cholesterol, Triglycerides)
Hide Description Lipid Profile (total cholesterol, high-density lipoproteins [HDL] cholesterol, low-density lipoproteins [LDL] cholesterol, triglycerides)was determined after an overnight fast. The change in lipid profile between baseline and 12 months is reported.
Time Frame Measured at baseline and Months 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.
Arm/Group Title TH9507 Placebo
Hide Arm/Group Description:

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months.

Participants received treatment with placebo medication.

Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months

Overall Number of Participants Analyzed 29 29
Mean (Standard Error)
Unit of Measure: mg/dL
Total Cholesterol 4  (4) 7  (5)
High-density lipoproteins [HDL] cholesterol 4  (1) 3  (1)
Low-density lipoproteins [LDL] cholesterol 4  (4) 1  (4)
Triglycerides -26  (16) 12  (8)
4.Secondary Outcome
Title Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test
Hide Description Glucose tolerance was determined after an overnight fast using standard 75 gram oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Change in glucose tolerance (fasting and 2 hour OGTT) between baseline and twelve months is reported.
Time Frame Measured at baseline and Months 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available. Data from 6 month is utilized in the linear mixed effects modeling.
Arm/Group Title TH9507 Placebo
Hide Arm/Group Description:

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months

Participants received treatment with placebo medication.

Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months

Overall Number of Participants Analyzed 29 29
Mean (Standard Error)
Unit of Measure: mg/dL
Fasting Glucose 2  (3) 1  (2)
2 Hour OGTT Glucose -11  (7) -3  (8)
5.Secondary Outcome
Title Change in Growth Hormone Pulse Characteristics (Median Pulse Mass) as Assessed by Overnight Frequent Sampling of Growth Hormone
Hide Description Overnight frequent sampling of growth hormone levels was performed and characteristics of pulsatile secretion were determine using automated deconvolution (using AutoDecon software). Based on the deconvolution, the median pulse mass (in nanograms per millileter of growth hormone) was calculated. A positive number indicates an increase in median pulse mass between baseline and 12 months.
Time Frame Measured at baseline and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data (all participants for whom change from baseline to 12 months was available)
Arm/Group Title TH9507 Placebo
Hide Arm/Group Description:

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months.

Participants received treatment with placebo medication.

Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months

Overall Number of Participants Analyzed 18 12
Mean (Standard Deviation)
Unit of Measure: nanograms/milliliter
0.54  (1.35) 0.20  (0.30)
6.Secondary Outcome
Title Mitochondrial Function (Post-exercise Phosphocreatine Recovery [ViPCr]) by 31P-MRS
Hide Description Change in post-exercise phosphocreatine recovery [ViPCr] between baseline and 12 months (positive change indicates increase in the variable between baseline and 12 months). ViPCR is the initial rate of phosphocreatine recovery normalized based on participant effort. Greater ViPCr represents relatively better mitochondrial function.
Time Frame Measured at Baseline and Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All available data. Assessment of mitochondrial function could not be performed in all patients.
Arm/Group Title TH9507 Placebo
Hide Arm/Group Description:

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

TH9507: Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months

Participants received treatment with placebo medication.

Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: milliMoles/second
0.01  (11.3) -1.02  (5.7)
Time Frame Safety visits occurred at 2 weeks, 1, 3, 6 and 9 months at which time fasting glucose and IGF-1 were monitored.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TH9507 Placebo
Hide Arm/Group Description

Participants received treatment with growth hormone releasing hormone 1-44 (TH9507).

Growth hormone releasing hormone (GHRH) 1-44 : 2-mg sub-cutaneous abdominal injections once daily for 12 months

Participants received treatment with placebo medication.

Placebo: 2-mg sub-cutaneous abdominal injections once daily for 12 months

All-Cause Mortality
TH9507 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TH9507 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TH9507 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/31 (90.32%)      26/29 (89.66%)    
Cardiac disorders     
Hypertension   8/31 (25.81%)  8 5/29 (17.24%)  5
Gastrointestinal disorders     
Abdominal pain   2/31 (6.45%)  2 3/29 (10.34%)  3
Constipation   2/31 (6.45%)  2 0/29 (0.00%)  0
Diarrhea   3/31 (9.68%)  3 1/29 (3.45%)  1
Gastroenteritis   2/31 (6.45%)  2 1/29 (3.45%)  1
Gastroesophageal reflux disease   0/31 (0.00%)  0 2/29 (6.90%)  2
Nausea   3/31 (9.68%)  3 0/29 (0.00%)  0
General disorders     
Mechanical injury   0/31 (0.00%)  0 3/29 (10.34%)  3
Toothache   2/31 (6.45%)  2 0/29 (0.00%)  0
Infections and infestations     
Fungal infection   0/31 (0.00%)  0 3/29 (10.34%)  3
Infection   0/31 (0.00%)  0 2/29 (6.90%)  2
Nasopharyngitis   0/31 (0.00%)  0 2/29 (6.90%)  2
Sinusitis   2/31 (6.45%)  2 6/29 (20.69%)  6
Upper respiratory tract infection   5/31 (16.13%)  5 7/29 (24.14%)  7
Metabolism and nutrition disorders     
Hyperglycemia   3/31 (9.68%)  3 2/29 (6.90%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia   2/31 (6.45%)  2 0/29 (0.00%)  0
Back pain   4/31 (12.90%)  4 4/29 (13.79%)  4
Musculoskeletal injury   5/31 (16.13%)  5 5/29 (17.24%)  5
Musculoskeletal pain   4/31 (12.90%)  4 5/29 (17.24%)  5
Myalgia   2/31 (6.45%)  2 3/29 (10.34%)  3
Tendonitis   2/31 (6.45%)  2 0/29 (0.00%)  0
Nervous system disorders     
Tingling/ Paresthesia   3/31 (9.68%)  3 1/29 (3.45%)  1
Fatigue   2/31 (6.45%)  2 1/29 (3.45%)  1
Headache   2/31 (6.45%)  2 5/29 (17.24%)  5
Psychiatric disorders     
Anxiety   1/31 (3.23%)  1 3/29 (10.34%)  3
Atypical chest pain   2/31 (6.45%)  2 2/29 (6.90%)  2
Depression   0/31 (0.00%)  0 2/29 (6.90%)  2
Skin and subcutaneous tissue disorders     
Injection site bruising   17/31 (54.84%)  17 21/29 (72.41%)  21
Injection-site bleeding   4/31 (12.90%)  4 5/29 (17.24%)  5
Injection-site pain   3/31 (9.68%)  3 2/29 (6.90%)  2
Injection site puritis   2/31 (6.45%)  2 1/29 (3.45%)  1
Injection site reaction   2/31 (6.45%)  2 0/29 (0.00%)  0
Injection site erythema   2/31 (6.45%)  2 0/29 (0.00%)  0
Dermatitis   3/31 (9.68%)  3 1/29 (3.45%)  1
Vascular disorders     
Peripheral edema   3/31 (9.68%)  3 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Steven K. Grinspoon MD
Organization: Massachusetts General Hospital
Phone: 617-726-3890