18 and older, any sex, with Acromegaly. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1Primary· 12 months
Percentage of participants with a reduction of mean GH levels to \<2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.
Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Overall
Group
Value
95% CI
Pasireotide LAR (Core)
31.3
24.5 – 38.7
Octreotide LAR (Core)
19.2
13.8 – 25.7
Post Surgery
Group
Value
95% CI
Pasireotide LAR (Core)
39.4
28.0 – 51.7
Octreotide LAR (Core)
21.8
13.2 – 32.6
De novo
Group
Value
95% CI
Pasireotide LAR (Core)
25.7
17.7 – 35.2
Octreotide LAR (Core)
17.3
10.6 – 26.0
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/LSecondary· 12 Months
Percentage of participants with a reduction of mean GH levels to \< 2.5μg/L (based on a 5-point 2-hour profile).
Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Overall
Group
Value
95% CI
Pasireotide LAR (Core)
48.3
40.7 – 55.9
Octreotide LAR (Core)
51.6
44.1 – 59.1
Post surgery
Group
Value
95% CI
Pasireotide LAR (Core)
52.1
39.9 – 64.1
Octreotide LAR (Core)
51.3
39.7 – 62.8
De novo
Group
Value
95% CI
Pasireotide LAR (Core)
45.7
36.0 – 55.7
Octreotide LAR (Core)
51.9
41.9 – 61.8
Change From Baseline in Tumor Volume at 12 MonthsSecondary· Baseline, 12 Months
Absolute and percentage change from baseline in tumor volume (assessed by pituitary MRI) Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Overall at baseline
Group
Value
95% CI
Pasireotide LAR (Core)
2420.7
± 4159.21
Octreotide LAR (Core)
2259.2
± 3390.20
Overall % change at month 12
Group
Value
95% CI
Pasireotide LAR (Core)
-39.7
± 21.83
Octreotide LAR (Core)
-38.0
± 24.47
Post surgery at baseline
Group
Value
95% CI
Pasireotide LAR (Core)
2185.2
± 2861.09
Octreotide LAR (Core)
2196.5
± 3922.08
Post surgery % change at month 12
Group
Value
95% CI
Pasireotide LAR (Core)
-39.5
± 20.60
Octreotide LAR (Core)
-39.0
± 23.81
De novo at baseline
Group
Value
95% CI
Pasireotide LAR (Core)
2592.4
± 4901.99
Octreotide LAR (Core)
2308.1
± 2930.84
De novo % change at month 12
Group
Value
95% CI
Pasireotide LAR (Core)
-39.9
± 22.65
Octreotide LAR (Core)
-37.2
± 25.07
Overall absolute change at month 12
Group
Value
95% CI
Pasireotide LAR (Core)
-987.1
± 2448.14
Octreotide LAR (Core)
-801.2
± 1676.62
Post surgery abs. change at month 12
Group
Value
95% CI
Pasireotide LAR (Core)
-873.7
± 1282.06
Octreotide LAR (Core)
-713.8
± 1708.20
Percentage of Participants With Normalization of IGF-1Secondary· 12 Months
Percentage of participants with normalization of sex- and age-adjusted IGF-1. Post surgery = patients with prior surgery but no previous medical treatment for acromegaly De novo = patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.
Overall
Group
Value
95% CI
Pasireotide LAR (Core)
38.6
31.4 – 46.3
Octreotide LAR (Core)
23.6
17.7 – 30.5
Post surgery
Group
Value
95% CI
Pasireotide LAR (Core)
50.7
38.6 – 62.8
Octreotide LAR (Core)
26.9
17.5 – 38.2
De novo
Group
Value
95% CI
Pasireotide LAR (Core)
30.5
21.9 – 40.2
Octreotide LAR (Core)
21.2
13.8 – 30.3
Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1Secondary· Months 3, 6, 9, 12, 16, 19, 22, 25
Percentage of participants with a reduction of mean GH levels to \< 2.5μg/L (based on a 5-point 2-hour profile) and normalization of sex- and age-adjusted IGF-1.
Denominator for time points up to Month 12 is the Full Analysis Set (FAS). Denominator for time points after Month 12 excludes patients who completed the core and did not enter the extension. Patients who discontinued were considered non-responders for the time points after discontinuation, patients who crossed over were considered non-responders for all time points after crossover. Analysis was based on data up to crossover (i.e., i
Month 3
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
30.1
23.4 – 37.5
Octreotide LAR (Core & Extension)
21.4
15.7 – 28.1
Month 6
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
30.1
23.4 – 37.5
Octreotide LAR (Core & Extension)
19.8
14.3 – 26.3
Month 9
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
27.8
21.4 – 35.1
Octreotide LAR (Core & Extension)
23.1
17.2 – 29.9
Month 12
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
29.0
22.4 – 36.3
Octreotide LAR (Core & Extension)
17.6
12.3 – 23.9
Month 16
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
25.2
18.4 – 33.0
Octreotide LAR (Core & Extension)
12.4
7.6 – 18.7
Month 19
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
23.1
16.6 – 30.8
Octreotide LAR (Core & Extension)
13.7
8.7 – 20.2
Month 22
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
25.2
18.4 – 33.0
Octreotide LAR (Core & Extension)
16.3
10.9 – 23.2
Month 25
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
24.5
17.8 – 32.3
Octreotide LAR (Core & Extension)
13.7
8.7 – 20.2
Summary of Mean GH ValuesSecondary· Baseline, Months 3, 6, 9, 12, 16, 19, 22, 25
Mean GH levels (based on a 5-point profile over 2 hours). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Baseline
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
21.9
± 32.14
Octreotide LAR (Core & Extension)
18.8
± 25.95
Month 3
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
6.3
± 12.54
Octreotide LAR (Core & Extension)
5.8
± 12.87
Month 6
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
5.6
± 11.47
Octreotide LAR (Core & Extension)
5.2
± 10.99
Month 9
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
4.9
± 9.62
Octreotide LAR (Core & Extension)
4.3
± 9.70
Month 12
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
4.6
± 9.51
Octreotide LAR (Core & Extension)
4.5
± 11.34
Month 16
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
2.3
± 5.64
Octreotide LAR (Core & Extension)
1.4
± 1.49
Month 19
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
2.1
± 5.68
Octreotide LAR (Core & Extension)
1.5
± 1.68
Month 22
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
2.1
± 6.15
Octreotide LAR (Core & Extension)
1.4
± 1.43
Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )Secondary· Up to 26 months
Time to first response for patients achieving a reduction of mean GH level to \< 2.5 μg/L and normalization of IGF-1. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
12.6
12.3 – 13.0
Octreotide LAR (Core & Extension)
12.4
12.3 – 13.7
Severity Scores of Acromegaly SymptomsSecondary· Baseline, Months 12, 25
Severity scores of acromegaly symptoms (Headache, Fatigue, Perspiration, Paresthesias, Osteoarthralgia). Symptoms were scored from 0 (no symptom) to 4 (very severe). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Headache - Baseline
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
0.9
± 1.05
Octreotide LAR (Core & Extension)
1.0
± 1.14
Fatigue - Baseline
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
1.2
± 1.13
Octreotide LAR (Core & Extension)
1.4
± 1.23
Perspiration - Baseline
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
1.1
± 1.21
Octreotide LAR (Core & Extension)
1.3
± 1.31
Paresthesia - Baseline
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
0.7
± 1.00
Octreotide LAR (Core & Extension)
0.8
± 1.15
Osteoarthraliga - Baseline
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
1.0
± 1.05
Octreotide LAR (Core & Extension)
1.3
± 1.26
Headache - M12
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
0.5
± 0.77
Octreotide LAR (Core & Extension)
0.6
± 0.79
Fatigue - M12
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
0.8
± 0.95
Octreotide LAR (Core & Extension)
0.7
± 0.99
Perspiration - M12
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
0.4
± 0.81
Octreotide LAR (Core & Extension)
0.5
± 0.91
Ring SizeSecondary· Baseline, Months 12, 25
Ring size (based on jeweler's finger gauge). Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Baseline left hand (LH) 4th digit
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
11.6
± 2.00
Octreotide LAR (Core & Extension)
11.8
± 1.97
Baseline left hand 5th digit
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
11.7
± 2.82
Octreotide LAR (Core & Extension)
12.4
± 2.88
Baseline right hand (RH) 4th digit
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
12.5
± 2.01
Octreotide LAR (Core & Extension)
11.4
± 2.54
Baseline right hand 5th digit
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
11.2
± 3.35
Octreotide LAR (Core & Extension)
11.3
± 2.95
M12 LH 4th digit
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
10.6
± 2.05
Octreotide LAR (Core & Extension)
11.1
± 1.95
M12 LH 5th digit
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
11.8
± 1.81
Octreotide LAR (Core & Extension)
12.4
± 1.78
M12 RH 4th digit
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
12.2
± 2.12
Octreotide LAR (Core & Extension)
11.3
± 2.18
M12 RH 5th digit
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
10.7
± 3.96
Octreotide LAR (Core & Extension)
10.5
± 2.14
Health-related Quality-of-life as Measured by the AcroQoL QuestionnaireSecondary· Baseline, Months 12, 25
Acromegalyy quality of life (AcroQoL) total scores. The AcroQoL questionnaire is unidimensional and contains 22 items divided in two scales: one that evaluates physical aspects (eight items) and another one that evaluates psychological aspects (14 items). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in
Baseline
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
58.4
± 19.97
Octreotide LAR (Core & Extension)
55.6
± 19.79
M12
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
65.7
± 21.64
Octreotide LAR (Core & Extension)
61.6
± 21.01
M25
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
69.3
± 18.76
Octreotide LAR (Core & Extension)
62.9
± 18.86
Summary of Prolactin LevelsSecondary· Baseline, Months 12, 25
Prolactin Levels. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Baseline
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
20.6
± 53.00
Octreotide LAR (Core & Extension)
15.8
± 22.05
M12
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
8.9
± 19.24
Octreotide LAR (Core & Extension)
11.7
± 19.09
M25
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
5.4
± 4.37
Octreotide LAR (Core & Extension)
6.7
± 4.63
Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)Secondary· Up to 26 months
The duration of response is defined as the time from the date that patient first met and maintained the response criteria based on primary efficacy variable to the date that patient lost response status.
Median and corresponding 95% CI are derived based on Kaplan-Meier method. Analysis was based on data up to crossover (i.e., included data from both blinded core and extension phase up to 26 Months for patients who continued the same treatment in the extension. For patients who switched to the other treatment, only data collected before crossover was included).
Group
Value
95% CI
Pasireotide LAR (Core & Extension)
64.4
52.1 – 100.4
Octreotide LAR (Core & Extension)
64.6
40.0 – 92.0
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.
The objective of this study was to compare the proportion of patients with a reduction of mean GH level to \<2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.
Following one year of treatment patients could proceed into the study extension.
Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03847207 — A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310
· Phase 1
· completed
NCT03103009 — Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia
· Phase 1
· completed
NCT02713776 — Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treat
· Phase 2
· completed
NCT02215070 — Pasireotide in Prevention of GI Toxicity
· Phase 2
· completed
NCT01794793 — Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
· Phase 4
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 2 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00600886.