NCT00675506

Brief Summary

Obesity, a condition that occurs when a person has too much body fat, affects about 31% of people in the United States. It is associated with increased risk of diabetes, high blood pressure, high cholesterol, and cardiovascular disease. Abdominal obesity, in particular, is also associated with low levels of growth hormone, a hormone that affects rate of growth and the way the body uses energy. Growth hormone releasing hormone (GHRH) is a substance that makes the body naturally increase its own growth hormone levels. Administering GHRH to people who are obese may help return their growth hormone levels to normal and, in turn, may lead to reduced abdominal fat and improved cardiovascular function. This study will evaluate the effectiveness of synthetic GHRH in decreasing the amount of abdominal fat and improving cardiovascular function in people who are obese.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 7, 2013

Completed
Last Updated

December 13, 2017

Status Verified

November 1, 2017

Enrollment Period

3.5 years

First QC Date

May 7, 2008

Results QC Date

October 23, 2012

Last Update Submit

November 16, 2017

Conditions

Abdominal ObesityGrowth Hormone Deficiency

Keywords

Growth Hormone Releasing HormoneGrowth Hormone PulseVisceral Adipose TissueCarotid Intima-Media Thickness

Outcome Measures

Primary Outcomes (1)

  • Change in Visceral Adipose Tissue Volume

    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.

    Measured at baseline and Months 6 and 12

Secondary Outcomes (5)

  • Change in Carotid Intima-media Thickness

    Measured at baseline and Months 6 and 12

  • Change in Lipid Profile (Total Cholesterol, High-density Lipoproteins [HDL] Cholesterol, Low-density Lipoproteins [LDL] Cholesterol, Triglycerides)

    Measured at baseline and Months 6 and 12

  • Change in Glucose Tolerance as Measured by Oral Glucose Tolerance Test

    Measured at baseline and Months 6 and 12

  • Change in Growth Hormone Pulse Characteristics (Median Pulse Mass) as Assessed by Overnight Frequent Sampling of Growth Hormone

    Measured at baseline and Month 12

  • Mitochondrial Function (Post-exercise Phosphocreatine Recovery [ViPCr]) by 31P-MRS

    Measured at Baseline and Month 12

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Growth hormone releasing hormone (GHRH) 1-44

2

PLACEBO COMPARATOR

Participants will receive treatment with placebo medication.

Drug: Placebo

Interventions

Growth hormone releasing hormone (GHRH) 1-44DRUG

2-mg sub-cutaneous injections once daily for 12 months

Also known as: TH9507
1
PlaceboDRUG

2-mg sub-cutaneous injections once daily for 12 months

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) greater than or equal to 30 kg/m2
  • Waist circumference greater than or equal to 102 cm in men and greater than or equal to 88 cm in women
  • Relative growth hormone (GH) deficiency, defined as a peak GH value of less than or equal to 8 ng/mL on Arginine-GHRH stimulation test
  • Hemoglobin level greater than 12.0 g/dL
  • Serum glutamic oxaloacetic transaminase and serum glutamic pyruvic transaminase less than 2.5 times the upper limit of normal
  • Creatinine level less than 1.5 mg/dL
  • Follicle stimulating hormone less than 20 IU/L in women
  • Negative mammogram within 1 year of study entry for women older than 40 years of age

You may not qualify if:

  • Obesity due to a known secondary cause (e.g., Cushing's syndrome, hypothyroidism) or a history of gastric bypass procedure
  • Known hypersensitivity to GHRH 1-44 (TH9507)
  • Known history of diabetes, fasting blood sugar less than 125 mg/dL, or antidiabetic drug use
  • Using any weight lowering drugs
  • Using estrogen, hormone replacement therapy, oral contraceptives, testosterone, glucocorticoids, anabolic steroids, GHRH, GH, or insulin-like growth factor-1 (IGF-1) within 3 months of study entry
  • Changes in lipid lowering or antihypertensive regimen within 3 months of study entry
  • Long-term illness, including anemia, chronic kidney disease, and liver disease
  • History of cancer (except patients with surgically cured basal cell or squamous cell skin cancers) or history of abnormalities on age appropriate malignancy screen, including mammography, colonoscopy, and prostate exam (or prostate specific antigen greater than 5 ng/mL)
  • History of hypopituitarism, pituitary surgery, pituitary/brain radiation, traumatic brain injury, or any other condition known to affect the growth hormone axis
  • History of any recent cardiovascular event, including heart attack, stroke, transient ischemic attack, unstable angina pectoris, or oxygen-dependent severe pulmonary disease, within 3 months of study entry
  • Clinical depression or other psychiatric illness that will not allow completion of the study as per investigator's judgement
  • History of or current eating disorder
  • History of recent alcohol or substance abuse (less than 1 year before study entry)
  • Positive pregnancy test or breastfeeding females and positive fecal occult blood test
  • Women of childbearing potential not currently using nonhormonal birth control methods, including barrier methods (e.g., IUD, condoms, diaphragms) or abstinence
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • Stanley TL, Feldpausch MN, Murphy CA, Grinspoon SK, Makimura H. Discordance of IGF-1 and GH stimulation testing for altered GH secretion in obesity. Growth Horm IGF Res. 2014 Feb;24(1):10-5. doi: 10.1016/j.ghir.2013.11.001. Epub 2013 Nov 15.

    PMID: 24291224DERIVED

  • Makimura H, Murphy CA, Feldpausch MN, Grinspoon SK. The effects of tesamorelin on phosphocreatine recovery in obese subjects with reduced GH. J Clin Endocrinol Metab. 2014 Jan;99(1):338-43. doi: 10.1210/jc.2013-3436. Epub 2013 Dec 20.

    PMID: 24178787DERIVED

  • Makimura H, Feldpausch MN, Rope AM, Hemphill LC, Torriani M, Lee H, Grinspoon SK. Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial. J Clin Endocrinol Metab. 2012 Dec;97(12):4769-79. doi: 10.1210/jc.2012-2794. Epub 2012 Sep 26.

    PMID: 23015655DERIVED

MeSH Terms

Conditions

Obesity, AbdominalDwarfism, Pituitary

Interventions

Growth Hormone-Releasing Hormonetesamorelin

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Results Point of Contact

Title
Steven K. Grinspoon MD
Organization
Massachusetts General Hospital
sgrinspoon@partners.org
617-726-3890

Study Officials

  • Steven K. Grinspoon, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 9, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 13, 2017

Results First Posted

January 7, 2013

Record last verified: 2017-11

Locations

US(1)