Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (NCT NCT04522180)
NCT ID: NCT04522180
Last Updated: 2024-10-03
Results Overview
IGF-1 is a hormone that manages the effects of growth hormone (GH) in the body. Baseline of IGF-1 is defined as the average value of Screening and Day 1. A negative percent change from Baseline indicated improvement.
COMPLETED
PHASE2
34 participants
Baseline to Week 27
2024-10-03
Participant Flow
Participants were enrolled at 22 investigational sites in United States of America, Estonia, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Russia, and Serbia from 4 January 2021 to 18Jan2022.
Participants with acromegaly were enrolled and assigned to receive an initial dose of GHR-LRX 120 mg or GHR-LRX 160 mg up to week 17 (when the first post-baseline IGF-1 results were available). After Week 17, patients may have received a higher dose up to 160 mg for efficacy, if necessary, up to 73 weeks.
Participant milestones
| Measure |
GHR-LRX 120 mg
Participants received GHR-LRX 120 mg subcutaneous (SC) injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX 160 mg
Participants received GHR-LRX 160 mg SC injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
Per Protocol Set (Initial Dose)
|
18
|
14
|
|
Overall Study
Increased Dose From Initial 120mg to Maximum Dose 160mg (Week 17 to Week 45)
|
15
|
0
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
GHR-LRX 120 mg
Participants received GHR-LRX 120 mg subcutaneous (SC) injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX 160 mg
Participants received GHR-LRX 160 mg SC injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3).
|
|---|---|---|
|
Overall Study
Investigator judgement
|
3
|
4
|
|
Overall Study
Voluntary withdrawal
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Adverse Event or Serious Adverse event
|
1
|
3
|
|
Overall Study
Reason not specified
|
8
|
5
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly
Baseline characteristics by cohort
| Measure |
GHR-LRX 120 mg
n=3 Participants
Participants received GHR-LRX 120 mg subcutaneous (SC) injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX 160 mg
n=31 Participants
Participants received GHR-LRX 160 mg SC injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.0 Years
STANDARD_DEVIATION 3.46 • n=5 Participants
|
51.9 Years
STANDARD_DEVIATION 11.76 • n=7 Participants
|
52.9 Years
STANDARD_DEVIATION 11.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
34 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
33 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
|
PRIMARY outcome
Timeframe: Baseline to Week 27Population: Per protocol set (total dose) included all FAS participants who completed at least 6 of the 8 doses of GHR-LRX with the first 27 Weeks administered and have no significant protocol deviations that would be expected to impact efficacy. Total dose includes results for IGF-1 reduction that combines both 120 mg and 160 mg doses. Analysis based on highest dose received as prespecified in the statistical analysis plan (SAP).
IGF-1 is a hormone that manages the effects of growth hormone (GH) in the body. Baseline of IGF-1 is defined as the average value of Screening and Day 1. A negative percent change from Baseline indicated improvement.
Outcome measures
| Measure |
GHR-LRX 120 mg (Per Protocol Set)
n=2 Participants
Participants received a maximum dose of GHR-LRX 120 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX 160 mg (Per Protocol Set)
n=24 Participants
Participants received a maximum dose of GHR-LRX 160 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX Total (Per Protocol Set)
n=26 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants in the Per Protocol Set (received maximum doses of 120 mg or 160 mg doses).
|
|---|---|---|---|
|
Percent Change in Insulin-like Growth Factor I (IGF-1) From Baseline to Week 27
|
-6.20 Percent change
Standard Deviation 10.803
|
-7.16 Percent change
Standard Deviation 20.100
|
-7.09 Percent change
Standard Deviation 19.402
|
SECONDARY outcome
Timeframe: At Week 27Population: Per protocol set (initial dose) includes all FAS participants who completed at least 6 of the 8 doses of GHR-LRX within the first 27 weeks administered and had no significant protocol deviations that would have been expected to impact efficacy. Here, overall number of participants analyzed signifies the number of participants available for analyses. Analysis based on highest dose received as prespecified in the statistical analysis plan (SAP).
Normalized IGF-1 level is defined as the ratio of the serum IGF-1 level and the participant's upper limit of normal (ULN).
Outcome measures
| Measure |
GHR-LRX 120 mg (Per Protocol Set)
n=2 Participants
Participants received a maximum dose of GHR-LRX 120 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX 160 mg (Per Protocol Set)
n=24 Participants
Participants received a maximum dose of GHR-LRX 160 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX Total (Per Protocol Set)
n=26 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants in the Per Protocol Set (received maximum doses of 120 mg or 160 mg doses).
|
|---|---|---|---|
|
Percentage of Participants Who Achieve Normalized IGF-1 Levels to Within 1.2 Times Gender and Age Limits at Day 183 (Week 27)
|
0 percentage of participants
Interval 0.0 to 84.2
|
0 percentage of participants
Interval 0.0 to 14.2
|
0 percentage of participants
Interval 0.0 to 13.2
|
SECONDARY outcome
Timeframe: At Week 27Population: Per protocol set (initial dose) includes all FAS participants who completed at least 6 of the 8 doses of GHR-LRX within the first 27 weeks administered and had no significant protocol deviations that would have been expected to impact efficacy. Here, overall number of participants analyzed signifies the number of participants available for analyses. Analysis based on highest dose received as prespecified in the statistical analysis plan (SAP).
Normalized IGF-1 level is defined as the ratio of the serum IGF-1 level and the participant's ULN.
Outcome measures
| Measure |
GHR-LRX 120 mg (Per Protocol Set)
n=2 Participants
Participants received a maximum dose of GHR-LRX 120 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX 160 mg (Per Protocol Set)
n=24 Participants
Participants received a maximum dose of GHR-LRX 160 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX Total (Per Protocol Set)
n=26 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants in the Per Protocol Set (received maximum doses of 120 mg or 160 mg doses).
|
|---|---|---|---|
|
Percentage of Participants Who Achieve Normalized IGF-1 Levels to Within 1.0 Times Gender and Age Limits at Day 183 (Week 27)
|
0 percentage of participants
Interval 0.0 to 84.2
|
0 percentage of participants
Interval 0.0 to 14.2
|
0 percentage of participants
Interval 0.0 to 13.2
|
SECONDARY outcome
Timeframe: Up to approximately 80 weeksPopulation: Per protocol set (maximum dose) includes all FAS participants who completed at least 6 of the 8 doses of GHR-LRX within the first 27 weeks administered and had no significant protocol deviations that would have been expected to impact efficacy. Here, 'Number analyzed' signifies the number of participants analyzed at specified time points.
IGF-1 is a hormone that manages the effects of growth hormone (GH) in the body. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
GHR-LRX 120 mg (Per Protocol Set)
n=3 Participants
Participants received a maximum dose of GHR-LRX 120 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX 160 mg (Per Protocol Set)
n=29 Participants
Participants received a maximum dose of GHR-LRX 160 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX Total (Per Protocol Set)
n=32 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants in the Per Protocol Set (received maximum doses of 120 mg or 160 mg doses).
|
|---|---|---|---|
|
Change From Baseline in Serum IGF-1 Over Time
At Week 3
|
-30.00 nanograms per milliliter (ng/mL)
Standard Deviation 44.908
|
5.03 nanograms per milliliter (ng/mL)
Standard Deviation 49.932
|
1.74 nanograms per milliliter (ng/mL)
Standard Deviation 49.896
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 17
|
-89.33 nanograms per milliliter (ng/mL)
Standard Deviation 136.433
|
136.433 nanograms per milliliter (ng/mL)
Standard Deviation 88.212
|
-41.82 nanograms per milliliter (ng/mL)
Standard Deviation 92.034
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 45
|
-86.75 nanograms per milliliter (ng/mL)
Standard Deviation 175.009
|
-52.80 nanograms per milliliter (ng/mL)
Standard Deviation 110.595
|
-55.75 nanograms per milliliter (ng/mL)
Standard Deviation 112.282
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 49
|
-81.75 nanograms per milliliter (ng/mL)
Standard Deviation 109.955
|
-64.59 nanograms per milliliter (ng/mL)
Standard Deviation 105.493
|
-66.23 nanograms per milliliter (ng/mL)
Standard Deviation 103.184
|
|
Change From Baseline in Serum IGF-1 Over Time
At Week 5
|
-50.67 nanograms per milliliter (ng/mL)
Standard Deviation 101.186
|
-45.53 nanograms per milliliter (ng/mL)
Standard Deviation 87.817
|
-46.01 nanograms per milliliter (ng/mL)
Standard Deviation 87.341
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 7
|
-84.33 nanograms per milliliter (ng/mL)
Standard Deviation 133.829
|
-39.46 nanograms per milliliter (ng/mL)
Standard Deviation 80.258
|
-43.66 nanograms per milliliter (ng/mL)
Standard Deviation 84.558
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 9
|
-109.00 nanograms per milliliter (ng/mL)
Standard Deviation 111.959
|
-25.28 nanograms per milliliter (ng/mL)
Standard Deviation 93.924
|
-33.13 nanograms per milliliter (ng/mL)
Standard Deviation 96.909
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 11
|
-157.67 nanograms per milliliter (ng/mL)
Standard Deviation 144.923
|
-14.28 nanograms per milliliter (ng/mL)
Standard Deviation 64.463
|
-27.73 nanograms per milliliter (ng/mL)
Standard Deviation 83.134
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 13
|
-89.67 nanograms per milliliter (ng/mL)
Standard Deviation 130.989
|
-38.01 nanograms per milliliter (ng/mL)
Standard Deviation 68.885
|
-42.85 nanograms per milliliter (ng/mL)
Standard Deviation 75.013
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 15
|
-112.00 nanograms per milliliter (ng/mL)
Standard Deviation 112.618
|
-28.97 nanograms per milliliter (ng/mL)
Standard Deviation 79.942
|
-37.28 nanograms per milliliter (ng/mL)
Standard Deviation 85.124
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 21
|
-123.25 nanograms per milliliter (ng/mL)
Standard Deviation 136.118
|
-51.91 nanograms per milliliter (ng/mL)
Standard Deviation 92.746
|
-57.39 nanograms per milliliter (ng/mL)
Standard Deviation 95.030
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 25
|
-99.75 nanograms per milliliter (ng/mL)
Standard Deviation 126.926
|
-36.99 nanograms per milliliter (ng/mL)
Standard Deviation 78.236
|
-41.82 nanograms per milliliter (ng/mL)
Standard Deviation 81.034
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 27
|
-58.75 nanograms per milliliter (ng/mL)
Standard Deviation 87.328
|
-49.45 nanograms per milliliter (ng/mL)
Standard Deviation 112.579
|
-50.16 nanograms per milliliter (ng/mL)
Standard Deviation 109.415
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 29
|
-90.25 nanograms per milliliter (ng/mL)
Standard Deviation 126.219
|
-40.25 nanograms per milliliter (ng/mL)
Standard Deviation 80.174
|
-44.25 nanograms per milliliter (ng/mL)
Standard Deviation 82.145
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 33
|
-75.25 nanograms per milliliter (ng/mL)
Standard Deviation 110.662
|
-53.12 nanograms per milliliter (ng/mL)
Standard Deviation 72.494
|
-54.89 nanograms per milliliter (ng/mL)
Standard Deviation 73.247
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 37
|
-98.75 nanograms per milliliter (ng/mL)
Standard Deviation 179.252
|
-32.55 nanograms per milliliter (ng/mL)
Standard Deviation 107.499
|
-37.85 nanograms per milliliter (ng/mL)
Standard Deviation 110.760
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 41
|
-93.25 nanograms per milliliter (ng/mL)
Standard Deviation 146.018
|
-43.12 nanograms per milliliter (ng/mL)
Standard Deviation 97.911
|
-47.13 nanograms per milliliter (ng/mL)
Standard Deviation 99.341
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 53
|
-90.25 nanograms per milliliter (ng/mL)
Standard Deviation 158.745
|
-68.71 nanograms per milliliter (ng/mL)
Standard Deviation 81.822
|
-70.86 nanograms per milliliter (ng/mL)
Standard Deviation 85.793
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 57
|
-73.75 nanograms per milliliter (ng/mL)
Standard Deviation 91.570
|
-59.43 nanograms per milliliter (ng/mL)
Standard Deviation 90.080
|
-60.93 nanograms per milliliter (ng/mL)
Standard Deviation 87.744
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 61
|
-125.75 nanograms per milliliter (ng/mL)
Standard Deviation 199.051
|
-83.08 nanograms per milliliter (ng/mL)
Standard Deviation 112.428
|
-88.10 nanograms per milliliter (ng/mL)
Standard Deviation 117.206
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 65
|
74.00 nanograms per milliliter (ng/mL)
Standard Deviation NA
Due to one participant, standard deviation (SD) was not estimable.
|
-103.30 nanograms per milliliter (ng/mL)
Standard Deviation 102.760
|
-88.52 nanograms per milliliter (ng/mL)
Standard Deviation 110.540
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 69
|
-22.00 nanograms per milliliter (ng/mL)
Standard Deviation NA
Due to one participant, standard deviation (SD) was not estimable.
|
-85.59 nanograms per milliliter (ng/mL)
Standard Deviation 53.018
|
-78.53 nanograms per milliliter (ng/mL)
Standard Deviation 53.934
|
|
Change From Baseline in Serum IGF-1 Over Time
Week 73
|
-1.00 nanograms per milliliter (ng/mL)
Standard Deviation NA
Due to one participant, standard deviation (SD) was not estimable.
|
-91.18 nanograms per milliliter (ng/mL)
Standard Deviation 79.166
|
-79.91 nanograms per milliliter (ng/mL)
Standard Deviation 79.928
|
SECONDARY outcome
Timeframe: Baseline, Week 3, 5, 7, 9, 11, 13, 15, 17, 21, 25, 27, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73Population: Per protocol set (maximum dose) includes all FAS participants who completed at least 6 of the 8 doses of GHR-LRX within the first 27 weeks administered and had no significant protocol deviations that would have been expected to impact efficacy. 'Number analyzed' signifies the number of participants analyzed at specified time points.
IGF-1 is a hormone that manages the effects of growth hormone (GH) in the body. A negative percent change from Baseline indicated improvement.
Outcome measures
| Measure |
GHR-LRX 120 mg (Per Protocol Set)
n=3 Participants
Participants received a maximum dose of GHR-LRX 120 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX 160 mg (Per Protocol Set)
n=29 Participants
Participants received a maximum dose of GHR-LRX 160 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX Total (Per Protocol Set)
n=32 Participants
Overall number of participants analyzed is the number of participants available for analyses. Total of all participants in the Per Protocol Set (received maximum doses of 120 mg or 160 mg doses).
|
|---|---|---|---|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 3
|
-3.73 percent change
Standard Deviation 5.072
|
2.64 percent change
Standard Deviation 11.936
|
2.04 percent change
Standard Deviation 11.571
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 5
|
-5.67 percent change
Standard Deviation 12.296
|
-8.28 percent change
Standard Deviation 18.158
|
-8.04 percent change
Standard Deviation 17.554
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 7
|
-9.57 percent change
Standard Deviation 16.297
|
-7.16 percent change
Standard Deviation 16.637
|
-7.39 percent change
Standard Deviation 16.360
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 9
|
-17.43 percent change
Standard Deviation 11.285
|
-2.95 percent change
Standard Deviation 16.995
|
-4.31 percent change
Standard Deviation 16.955
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 11
|
-26.56 percent change
Standard Deviation 15.966
|
-1.15 percent change
Standard Deviation 16.235
|
-3.54 percent change
Standard Deviation 17.638
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 13
|
-10.32 percent change
Standard Deviation 17.934
|
-6.35 percent change
Standard Deviation 16.837
|
-6.72 percent change
Standard Deviation 16.679
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 15
|
-17.81 percent change
Standard Deviation 13.377
|
-5.40 percent change
Standard Deviation 21.168
|
-6.64 percent change
Standard Deviation 20.698
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 17
|
-9.36 percent change
Standard Deviation 20.529
|
-4.59 percent change
Standard Deviation 20.631
|
-5.04 percent change
Standard Deviation 20.338
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 21
|
-19.07 percent change
Standard Deviation 8.695
|
-9.98 percent change
Standard Deviation 22.994
|
-10.68 percent change
Standard Deviation 22.261
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 25
|
-13.28 percent change
Standard Deviation 12.010
|
-6.58 percent change
Standard Deviation 16.164
|
-7.10 percent change
Standard Deviation 15.794
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 27
|
-6.20 percent change
Standard Deviation 10.803
|
-7.16 percent change
Standard Deviation 20.100
|
-7.09 percent change
Standard Deviation 19.402
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 29
|
-10.55 percent change
Standard Deviation 14.242
|
-7.92 percent change
Standard Deviation 18.173
|
-8.13 percent change
Standard Deviation 17.656
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 33
|
-8.10 percent change
Standard Deviation 13.484
|
-10.10 percent change
Standard Deviation 16.351
|
-9.94 percent change
Standard Deviation 15.905
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 37
|
-6.25 percent change
Standard Deviation 27.791
|
-4.29 percent change
Standard Deviation 25.161
|
-4.45 percent change
Standard Deviation 24.755
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 41
|
-8.89 percent change
Standard Deviation 19.345
|
-9.01 percent change
Standard Deviation 23.250
|
-9.00 percent change
Standard Deviation 22.608
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 45
|
-3.24 percent change
Standard Deviation 29.617
|
-8.26 percent change
Standard Deviation 23.791
|
-7.82 percent change
Standard Deviation 23.590
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 49
|
-10.12 percent change
Standard Deviation 11.603
|
-12.83 percent change
Standard Deviation 22.932
|
-12.57 percent change
Standard Deviation 21.924
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 53
|
-6.37 percent change
Standard Deviation 23.892
|
-14.81 percent change
Standard Deviation 19.811
|
-13.97 percent change
Standard Deviation 19.697
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 57
|
-10.11 percent change
Standard Deviation 8.205
|
-10.50 percent change
Standard Deviation 19.795
|
-10.46 percent change
Standard Deviation 18.763
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 61
|
-11.72 percent change
Standard Deviation 26.723
|
-18.94 percent change
Standard Deviation 25.675
|
-18.09 percent change
Standard Deviation 25.044
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 65
|
35.41 percent change
Standard Deviation NA
Due to one participant, standard deviation (SD) was not estimable.
|
-21.36 percent change
Standard Deviation 25.392
|
-16.63 percent change
Standard Deviation 29.235
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 69
|
-10.53 percent change
Standard Deviation NA
Due to one participant, standard deviation (SD) was not estimable.
|
-23.32 percent change
Standard Deviation 14.391
|
-21.89 percent change
Standard Deviation 14.120
|
|
Percent Change From Baseline in Serum IGF-1 Over Time
At Week 73
|
-0.48 percent change
Standard Deviation NA
Due to one participant, standard deviation (SD) was not estimable.
|
-22.62 percent change
Standard Deviation 20.556
|
-19.85 percent change
Standard Deviation 20.578
|
Adverse Events
GHR-LRX 120 mg (Safety Set)
GHR-LRX 160 mg (Safety Set)
GHR-LRX Total (Safety Set)
Serious adverse events
| Measure |
GHR-LRX 120 mg (Safety Set)
n=3 participants at risk
Participants received a maximum dose of GHR-LRX 120 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX 160 mg (Safety Set)
n=31 participants at risk
Participants received a maximum dose of GHR-LRX 160 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3). Due to the length of the study after Week 17, participants received the maximum dose longer than the initial dose.
|
GHR-LRX Total (Safety Set)
n=34 participants at risk
Overall number of participants (34) analyzed is the number of participants available for analyses.
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
3.2%
1/31 • Number of events 1 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • Number of events 1 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Infections and infestations
COVID-19 pneumonia
|
33.3%
1/3 • Number of events 1 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • Number of events 1 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
3.2%
1/31 • Number of events 1 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • Number of events 1 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
Other adverse events
| Measure |
GHR-LRX 120 mg (Safety Set)
n=3 participants at risk
Participants received a maximum dose of GHR-LRX 120 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3).
|
GHR-LRX 160 mg (Safety Set)
n=31 participants at risk
Participants received a maximum dose of GHR-LRX 160 mg SC injection once every month for up to 73 weeks with a booster dose administered on Day 15 (Week 3). Due to the length of the study after Week 17, participants received the maximum dose longer than the initial dose.
|
GHR-LRX Total (Safety Set)
n=34 participants at risk
Overall number of participants (34) analyzed is the number of participants available for analyses.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
19.4%
6/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
20.6%
7/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Infections and infestations
Respiratory tract infection viral
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
9.7%
3/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
11.8%
4/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
12.9%
4/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
11.8%
4/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
9.7%
3/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
8.8%
3/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Infections and infestations
Pyelonephritis chronic
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
35.5%
11/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
32.4%
11/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
9.7%
3/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
8.8%
3/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
12.9%
4/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
14.7%
5/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
12.9%
4/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
11.8%
4/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
9.7%
3/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
8.8%
3/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
3.2%
1/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Haemorrhoids
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
3.2%
1/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
9.7%
3/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
11.8%
4/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
8.8%
3/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
9.7%
3/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
8.8%
3/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Investigations
Lipase increased
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Investigations
Weight increased
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
General disorders
Asthenia
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
12.9%
4/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
14.7%
5/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
16.1%
5/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
14.7%
5/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
3.2%
1/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
8.8%
3/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
9.7%
3/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
8.8%
3/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
6.5%
2/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Renal and urinary disorders
Renal cyst
|
66.7%
2/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
5.9%
2/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Hepatobiliary disorders
Hepatic cyst
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
|
Injury, poisoning and procedural complications
Post procedural hypothyroidism
|
33.3%
1/3 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
0.00%
0/31 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
2.9%
1/34 • From Day 1 up to the end of study follow-up (up to week 121).
All participants who were randomized and received at least 1 dose of GHR-LRX. Data for all-cause mortality, serious and non-serious adverse events is reported as per the maximum dose received by participants per arm considering dose escalation was allowed in this study. Adverse events collected based on highest dose received as prespecified in the statistical analysis plan (SAP).
|
Additional Information
Ionis Pharmaceuticals, Inc.
Ionis Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Principal investigators are not employees of Ionis Pharmaceuticals. Work with CDT to establish the Principal Investigator agreement.
- Publication restrictions are in place
Restriction type: OTHER