Trial · NCT03375788
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
NCT03375788, Phase 2, Completed, Massachusetts General Hospital; results first posted 2025-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk. Trials, record NCT03375788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03375788
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
- NCT number
- NCT03375788
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity, Obesity, Abdominal, Liver Fat, Fatty Liver
- Interventions
- Tesamorelin, Identical Placebo
- First posted
- 2017-12-18
- Last updated
- 2025-11-20
- Results first posted
- 2025-11-20
- Limitations and caveats
Interpretation of changes in biopsy data are limited by relatively small sample size as well as the requirement for steatosis but not steatohepatitis at baseline. In other words, not all participants had steatohepatitis or fibrosis at baseline.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Liver Fat Content | change from baseline to 12 months | Liver Fat Content as measured by hydrogen-magnetic resonance spectroscopy. All available data used; data not available for 1 participant in tesamorelin group and 3 participants in placebo group. |
| Secondary | NAFLD Activity Score | change from baseline to 12 months | Nonalcoholic Fatty Liver Disease Activity Score (NAS, scored between 0-8, with higher indicating more severe disease) from liver biopsy. All available data used; data not available for 3 participants in placebo group and 1 participant in tesamorelin group. |
| Secondary | Low Density Lipoprotein (LDL) Cholesterol | change from baseline to 12 months | All available data utilized. Data not available for 2 participants in tesamorelin group and 3 participants in placebo group. |
| Secondary | C-reactive Protein | change from baseline to 12 months | All available data utilized. Data not available for 2 participants in placebo group. |
| Secondary | Fibrosis Score | change from baseline to 12 months | fibrosis score from liver biopsy; all available data used - data not available for 1 participant in tesamorelin group and 3 participants in placebo group. Fibrosis stage scored from 0-4, where 0 indicates no fibrosis and 4 indicates most severe fibrosis, which is cirrhosis. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Liver Fat Content | change from baseline to 12 months | percent change in hepatic fat fraction | MEDIAN | |
| SECONDARY | NAFLD Activity Score | change from baseline to 12 months | units on a scale | MEDIAN | |
| SECONDARY | Low Density Lipoprotein (LDL) Cholesterol | change from baseline to 12 months | milligrams per deciliter | MEAN | |
| SECONDARY | C-reactive Protein | change from baseline to 12 months | milligrams per liter (mg/L) | MEAN | |
| SECONDARY | Fibrosis Score | change from baseline to 12 months | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Liver Fat Content | Tesamorelin | -5.3 | Inter-Quartile Range -13.0 to -1.4 | percent change in hepatic fat fraction | |
| Liver Fat Content | Placebo | 3.6 | Inter-Quartile Range -6.2 to 7.9 | percent change in hepatic fat fraction | |
| NAFLD Activity Score | Tesamorelin | 0 | Inter-Quartile Range -2 to 0 | units on a scale | |
| NAFLD Activity Score | Placebo | 0 | Inter-Quartile Range -1 to 1 | units on a scale | |
| Low Density Lipoprotein (LDL) Cholesterol | Tesamorelin | -5.7 | Standard Deviation 27 | milligrams per deciliter | |
| Low Density Lipoprotein (LDL) Cholesterol | Placebo | -0.7 | Standard Deviation 16 | milligrams per deciliter | |
| C-reactive Protein | Tesamorelin | -0.9 | Standard Deviation 4.2 | milligrams per liter (mg/L) | |
| C-reactive Protein | Placebo | 0.0 | Standard Deviation 4.1 | milligrams per liter (mg/L) | |
| Fibrosis Score | Tesamorelin | 0 | Inter-Quartile Range 0 to 1 | units on a scale | |
| Fibrosis Score | Placebo | 0 | Inter-Quartile Range 0 to 0.5 | units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 12-month Double-blind Phase | STARTED | Tesamorelin | 26 | |
| 12-month Double-blind Phase | STARTED | Placebo | 25 | |
| 12-month Double-blind Phase | COMPLETED | Tesamorelin | 19 | |
| 12-month Double-blind Phase | COMPLETED | Placebo | 19 | |
| 12-month Double-blind Phase | NOT COMPLETED | Tesamorelin | 7 | |
| 12-month Double-blind Phase | NOT COMPLETED | Placebo | 6 | |
| 6 Month Open Label Phase | STARTED | Tesamorelin | 17 | |
| 6 Month Open Label Phase | STARTED | Placebo | 13 | |
| 6 Month Open Label Phase | COMPLETED | Tesamorelin | 16 | |
| 6 Month Open Label Phase | COMPLETED | Placebo | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Double-blind Phase: Tesamorelin | 0 | 26 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Double-blind Phase: Placebo | 1 | 25 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Open Label Phase | 1 | 30 | 1 |
| other | Acne | Skin and subcutaneous tissue disorders | Double-blind Phase: Tesamorelin | 1 | 26 | 1 |
| other | Acne | Skin and subcutaneous tissue disorders | Double-blind Phase: Placebo | 0 | 25 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Open Label Phase | 1 | 30 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Double-blind Phase: Tesamorelin | 6 | 26 | 10 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Double-blind Phase: Placebo | 1 | 25 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Open Label Phase | 2 | 30 | 3 |
| other | Carpal Tunnel Syndrome | Musculoskeletal and connective tissue disorders | Double-blind Phase: Tesamorelin | 0 | 26 | 0 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind Phase: Tesamorelin | 0 | 26 |
| Total, all-cause mortality | Double-blind Phase: Placebo | 0 | 25 |
| Total, all-cause mortality | Open Label Phase | 0 | 30 |
| Total, other adverse events | Double-blind Phase: Tesamorelin | 22 | 26 |
| Total, other adverse events | Double-blind Phase: Placebo | 15 | 25 |
| Total, other adverse events | Open Label Phase | 16 | 30 |
| Total, serious adverse events | Double-blind Phase: Tesamorelin | 2 | 26 |
| Total, serious adverse events | Double-blind Phase: Placebo | 3 | 25 |
| Total, serious adverse events | Open Label Phase | 0 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK114144 | Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk | STANLEY, TAKARA LEAH; COREY, KATHLEEN ELIZABETH | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2018 to 2022 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03375788
GET https://conductscience.org/api/trials/v1/NCT03375788/events?page=2