Trial Outcomes & Findings for Effect of a Ghrelin Receptor Agonist on Muscle and Bone (NCT NCT04021706)
NCT ID: NCT04021706
Last Updated: 2024-03-27
Results Overview
to be assessed by D3-creatine dilution
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
baseline and 12 months
Results posted on
2024-03-27
Participant Flow
Participant milestones
| Measure |
Anamorelin
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Anamorelin
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Effect of a Ghrelin Receptor Agonist on Muscle and Bone
Baseline characteristics by cohort
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
75.7 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
74.5 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 monthsto be assessed by D3-creatine dilution
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Total Body Muscle Mass
Baseline
|
21.8 kg units on a scale
Standard Deviation 4.8
|
20.8 kg units on a scale
Standard Deviation 6.0
|
|
Total Body Muscle Mass
12 month visit
|
22.2 kg units on a scale
Standard Deviation 5.6
|
20.8 kg units on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: baseline and 12 monthsa serum biomarker of bone formation
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Serum Procollagen 1 Intact N-terminal (P1NP)
baseline
|
42.0 micrograms/L
Standard Deviation 16.5
|
45.9 micrograms/L
Standard Deviation 33.7
|
|
Serum Procollagen 1 Intact N-terminal (P1NP)
12 month visit
|
74.1 micrograms/L
Standard Deviation 45.4
|
46.2 micrograms/L
Standard Deviation 31.9
|
SECONDARY outcome
Timeframe: baseline and 12 monthsto be assessed by fasting blood drawn after 12 hour fast
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Fasting Plasma Glucose
baseline
|
95 mg/dL
Standard Deviation 8.0
|
100 mg/dL
Standard Deviation 8.0
|
|
Fasting Plasma Glucose
12 month visit
|
102 mg/dL
Standard Deviation 16
|
97 mg/dL
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: baseline and 12 monthsto be assessed by blood drawn after 12 hour fast
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Serum Aspartate Transaminase (AST)
baseline
|
23.2 U/L
Standard Deviation 9.6
|
17.9 U/L
Standard Deviation 3.8
|
|
Serum Aspartate Transaminase (AST)
12 month visit
|
21.8 U/L
Standard Deviation 8.4
|
17.8 U/L
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: baseline and 12 monthsto be assessed by blood drawn after 12 hour fast
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Alanine Transaminase (ALT)
baseline
|
16.8 U/L
Standard Deviation 6.9
|
17.8 U/L
Standard Deviation 7.9
|
|
Alanine Transaminase (ALT)
12 month visit
|
15.8 U/L
Standard Deviation 5.9
|
15.9 U/L
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: between baseline and 12 monthsNumber of participants with symptoms and any adverse events
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Number of Participants With Symptoms and Any Adverse Events
Myalgia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Symptoms and Any Adverse Events
Mild GI complaints
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline and 12 monthsDual energy X-ray absorptiometry (DXA) lean mass of arms plus legs
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Appendicular Lean Mass (ALM)
baseline
|
20.8 kg
Standard Deviation 4.4
|
18.3 kg
Standard Deviation 3.8
|
|
Appendicular Lean Mass (ALM)
12 month visit
|
20.8 kg
Standard Deviation 4.4
|
18.0 kg
Standard Deviation 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 12 monthsmeasure muscle strength and performance using grip strength dynamometer
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Handgrip Strength
baseline
|
28.1 kg
Standard Deviation 8.3
|
25.0 kg
Standard Deviation 6.7
|
|
Handgrip Strength
12 month visit
|
28.4 kg
Standard Deviation 8.4
|
26.3 kg
Standard Deviation 7.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 12 monthsmeasure muscle strength and performance using Biodex Isokinetic Dynamometer
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Isokinetic Leg Strength
knee flexion at 240 degrees/sec - baseline
|
27.5 Nm
Standard Deviation 11.4
|
27.2 Nm
Standard Deviation 9.0
|
|
Isokinetic Leg Strength
knee flexion at 240 degrees/s, 12 month visit
|
34.0 Nm
Standard Deviation 11.2
|
27.8 Nm
Standard Deviation 8.2
|
|
Isokinetic Leg Strength
knee extension at 240 degrees/sec - baseline
|
61.0 Nm
Standard Deviation 18.5
|
56.1 Nm
Standard Deviation 18.6
|
|
Isokinetic Leg Strength
knee extension at 240 degrees/sec, 12 month visit
|
65.2 Nm
Standard Deviation 18.9
|
55.9 Nm
Standard Deviation 18.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 12 monthslower extremity performance score, scale from 0 (worst performance) to 4 (best performance)
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Health Aging and Body Composition-Physical Performance Battery
baseline
|
2.25 score on a scale of 0 to 4
Standard Deviation 0.4
|
2.22 score on a scale of 0 to 4
Standard Deviation 0.4
|
|
Health Aging and Body Composition-Physical Performance Battery
12 month visit
|
2.43 score on a scale of 0 to 4
Standard Deviation 0.4
|
2.35 score on a scale of 0 to 4
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 12 monthsanabolic intermediary of growth hormone
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Serum Insulin Like Growth Factor-1 (IGF-1)
12 month visit
|
162 ng/mL
Standard Deviation 47
|
107 ng/mL
Standard Deviation 38
|
|
Serum Insulin Like Growth Factor-1 (IGF-1)
baseline
|
108 ng/mL
Standard Deviation 14
|
110 ng/mL
Standard Deviation 22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 12 monthsbone resorption marker
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Serum C-telopeptide (CTX)
baseline
|
0.69 ng/mL
Standard Deviation 0.2
|
0.72 ng/mL
Standard Deviation 0.3
|
|
Serum C-telopeptide (CTX)
12 month visit
|
0.73 ng/mL
Standard Deviation 0.3
|
0.64 ng/mL
Standard Deviation 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and 12 monthsassessed by DXA
Outcome measures
| Measure |
Anamorelin
n=13 Participants
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=13 Participants
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Bone Mineral Density of the Spine and Hip
Spine BMD at baseline
|
1.03 g/cm^2
Standard Deviation 0.16
|
1.08 g/cm^2
Standard Deviation 0.17
|
|
Bone Mineral Density of the Spine and Hip
Spine BMD at 12 months
|
1.04 g/cm^2
Standard Deviation 0.16
|
1.09 g/cm^2
Standard Deviation 0.17
|
|
Bone Mineral Density of the Spine and Hip
Femoral neck BMD at baseline
|
0.73 g/cm^2
Standard Deviation 0.06
|
0.73 g/cm^2
Standard Deviation 0.08
|
|
Bone Mineral Density of the Spine and Hip
Femoral neck BMD at 12 months
|
0.72 g/cm^2
Standard Deviation 0.06
|
0.71 g/cm^2
Standard Deviation 0.07
|
Adverse Events
Anamorelin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Microcrystaline Cellulose
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anamorelin
n=17 participants at risk
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=15 participants at risk
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Renal and urinary disorders
hematuria
|
5.9%
1/17 • Number of events 2 • 12 months
|
0.00%
0/15 • 12 months
|
|
Cardiac disorders
heart valve regurgitation
|
0.00%
0/17 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Anamorelin
n=17 participants at risk
one 100 mg tablet daily, taken one hour before breakfast
Anamorelin Hydrochloride: Ghrelin receptor agonist
|
Microcrystaline Cellulose
n=15 participants at risk
one identical appearing tablet daily, taken one hour before breakfast
Placebo: placebo is a inert substance
|
|---|---|---|
|
Gastrointestinal disorders
GI bloating
|
11.8%
2/17 • Number of events 2 • 12 months
|
0.00%
0/15 • 12 months
|
|
Cardiac disorders
leaky heart valve
|
0.00%
0/17 • 12 months
|
6.7%
1/15 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
high blood sugar
|
5.9%
1/17 • Number of events 1 • 12 months
|
0.00%
0/15 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place