Back to resultsSafety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IONIS-GHR-LRx
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, IONIS-GHR-LRx
Eligibility Criteria
Inclusion Criteria:
- Males or females with documented diagnosis of acromegaly, aged 18-75 years old (inclusive) at the time of informed consent
- Participants must be on stable maximum or maximally tolerated dose of SRL (Lanreotide Autogel or Octreotide LAR, per treating physician judgment) every 28 days for a minimum of 3 months prior to screening and will be required to continue their stable dose of SRL throughout the study. Prior use of other medications for treating acromegaly is allowed but not within 6 weeks of screening.
- At Screening, serum insulin-like growth factor 1 (IGF-1) (performed at central lab) between 1.3 to 5 x upper limit of normal (ULN), inclusive, adjusted for age and sex
- Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, abstinent, or using 1 highly effective method of birth control
Exclusion Criteria:
- Participants who received surgery for pituitary adenoma within the last 6 months before the trial, or planning to receive surgery during the trial
- Participants who received radiotherapy for pituitary adenoma within the last 3 years before the trial, and/or planning to receive radiotherapy during the trial
- Participants with pituitary tumor that, per Investigator judgement, is worsening as assessed by pituitary/sellar magnetic resonance imaging (MRI) protocol at Screen or within 6 months of screening
- Evidence of decompensated cardiac function per medical judgement and/or New York Heart Association (NYHA) class 3 or 4
- Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment
- Participants may not have chronic systemic use of glucocorticoids, weight loss medications or participate in weight loss programs within 2 months before randomization and during study participation.
- Participants on anti-diabetes medication or estrogen containing medications must be on a stable dose and regimen for >= 3 months prior to screening and throughout the trial
- Participants taking glucagon-like peptide 1 (GLP-1) agonists or insulin can be allowed with prior consultation with the Sponsor Medical Monitor
Sites / Locations
- University of Alabama at Birmingham (UAB)
- St. Joseph's Hospital and Medical Center
- Northwestern University
- Palm Research Center, Inc.
- Palm Research Center, Inc.
- Memorial Sloan Kettering Cancer Center
- Oregon Health & Science University (OHSU)
- Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
- Debreceni Egyetem Klinikai Kozpont
- Szeged University - Szent-Gyorgyi Albert Clinical Center - I. Belgyógyászati Klinika (Internal Medicine)
- Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos - Hospital of Oncology
- Vaidoto Urbanaviciaus Individuali imone - Endokrinologijos klinika
- B_Serwis Popenda Sp. J. Specjalistyczna Przychodnia Lekarsk
- Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
- Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o. o.
- Twoja Przychodnia - Centrum Medyczne Nowa Sol
- Mazowiecki Szpital Brodnowski - Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i Diabetologii
- Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
- Centrul Medical Unirea - Bucuresti, Endocrinologie
- Spitalul Clinic Judetean de Urgenta Cluj - Napoca
- Spitalul Clinic Judetean Mures
- Spitalul Clinic Judetean de Urgenta Timisoara
- Multi-field Medical Clinic Anturium LLC
- Interregional Clinical Diagnostic Center
- Kuzbass Clinical Hospital n.a. S.V. Belyaev
- Federal State Budget Institution "National Medical Research Center of Endocrinology" of the Ministry of Healthcare of the Russian Federation
- I.M. Sechenov Moscow First State Medical University
- Novosibirsk State Regional Clinical Hospital
- Orenburg Regional Clinical Hospital, Endocrinology Department
- Rostov State Medical University
- Almazov National Medical Research Centre
- State Budget Healthcare Institution of the Tver Region
- Clinical Center of Serbia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
Cohort A: IONIS GHR-LRx, 60 mg
Cohort B: IONIS GHR-LRx, 80 mg
Cohort C: IONIS GHR-LRx, 120 mg
Cohort D: IONIS GHR-LRx, 160 mg
Arm Description
Participants received placebo by subcutaneous injection (SC) once every 4 weeks for 16 weeks.
Participants received IONIS GHR-LRx, 60 milligrams (mg), SC, once every 4 weeks for 16 weeks.
Participants received IONIS GHR-LRx, 80 mg, SC, once every 4 weeks for 16 weeks.
Participants received IONIS GHR-LRx, 120 mg, SC, once every 4 weeks for 16 weeks.
Participants received IONIS GHR-LRx, 160 mg, SC, once every 4 weeks for 16 weeks.
Outcomes
Primary Outcome Measures
Percent Change in Serum Insulin-like Growth Factor-1 (IGF-1) From Baseline to 28 Days After Last Dose
IGF-1 is a hormone that manages the effects of growth hormone (GH) in the body. Percent change from Baseline in IGF-1 levels was measured at Day 141. Baseline was defined as the last non-missing value prior to the first administration of Study Drug (ISIS 766720 or placebo). A negative percent change from Baseline indicated improvement. To perform a meaningful assessment of the pharmacodynamic (PD) activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an adverse event that occurred after the initiation of study drug dosing and before the end of the follow-up period.
Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings
Vitals signs included blood pressure, heart rate, respiratory rate, and temperature recorded throughout the study. Clinical significance was determined by the investigator.
Number of Participants With TEAEs Related to Clinically Significant Physical Examination Findings
Physical examination included weight and body mass index (BMI) recorded throughout the study. Clinical significance was determined by the investigator.
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings
Clinical laboratory assessments included clinical chemistry, hematology, and urinalysis. Clinically-significant abnormal laboratory values were reported as TEAEs if the results may, in the opinion of the Investigator, constitute or be associated with an AE.
Number of Participants With TEAEs Related to Clinically Significant Electrocardiogram (ECG) Findings
ECG assessments included QT, QRS duration, PR interval, ventricular rate, QTcB, QTcF.
Secondary Outcome Measures
Number of Participants Achieving Normalized IGF-1 Levels to Within 1.2 Times of Gender and Age Limits at 28 Days After Last Dose
Normalization of circulating IGF-1 is a validated marker for the treatment of acromegaly. IGF-1 assessments were based on a single serum sample taken in fasting conditions, prior to the study drug administration. Normal IGF-1 levels for a participant differ based on age and gender. Number of participants with a normal IGF-1 level which were 1.2 times within gender and age limits after 28 days of the last dose (Day 141) are presented. To perform a meaningful assessment of the pharmacodynamic activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.
Number of Participants Achieving Normalized IGF-1 Levels to Within 1.0 Times of Gender and Age Limits at 28 Days After Last Dose
Normalization of circulating IGF-1 is a validated marker for the treatment of acromegaly. IGF-1 assessments were based on a single serum sample taken in fasting conditions, prior to the study drug administration. Normal IGF-1 levels for a participant differ based on age and gender. Number of participants with a normal IGF-1 level which were 1.0 times within gender and age limits after 28 days of the last dose (Day 141) are presented. To perform a meaningful assessment of the pharmacodynamic activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.
Change From Baseline in Serum IGF-1 Over Time
IGF-1 is a hormone that manages the effects of GH in the body. Change from Baseline in IGF-1 levels was measured at multiple timepoints up to Day 211. Baseline was defined as the last non-missing value prior to the first administration of Study Drug (ISIS 766720 or placebo). A negative change from Baseline indicated improvement. To perform a meaningful assessment of the pharmacodynamic activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.
Percent Change From Baseline in Serum IGF-1 Over Time
IGF-1 is a hormone that manages the effects of GH in the body. Percent change from Baseline in IGF-1 levels was measured at multiple timepoints up to Day 211. Baseline was defined as the last non-missing value prior to the first administration of Study Drug (ISIS 766720 or placebo). A negative percent change from Baseline indicated improvement. To perform a meaningful assessment of the pharmacodynamic activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.
Full Information
NCT ID
NCT03548415
First Posted
May 22, 2018
Last Updated
October 21, 2022
Sponsor
Ionis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03548415
Brief Title
Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Official Title
A Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS-GHR-LRx, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (SRL)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
April 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to assess the safety, tolerability, and efficacy of IONIS-GHR-LRx in up to 60 participants with acromegaly.
Detailed Description
This short-term study assessed changes in serum insulin-like growth factor 1 (IGF-1) over a 16-week treatment period in a participant population diagnosed with acromegaly being treated with long-acting somatostatin receptor ligands (SRL).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, IONIS-GHR-LRx
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo by subcutaneous injection (SC) once every 4 weeks for 16 weeks.
Arm Title
Cohort A: IONIS GHR-LRx, 60 mg
Arm Type
Experimental
Arm Description
Participants received IONIS GHR-LRx, 60 milligrams (mg), SC, once every 4 weeks for 16 weeks.
Arm Title
Cohort B: IONIS GHR-LRx, 80 mg
Arm Type
Experimental
Arm Description
Participants received IONIS GHR-LRx, 80 mg, SC, once every 4 weeks for 16 weeks.
Arm Title
Cohort C: IONIS GHR-LRx, 120 mg
Arm Type
Experimental
Arm Description
Participants received IONIS GHR-LRx, 120 mg, SC, once every 4 weeks for 16 weeks.
Arm Title
Cohort D: IONIS GHR-LRx, 160 mg
Arm Type
Experimental
Arm Description
Participants received IONIS GHR-LRx, 160 mg, SC, once every 4 weeks for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
IONIS-GHR-LRx
Intervention Description
IONIS GHR-LRx administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered subcutaneously.
Primary Outcome Measure Information:
Title
Percent Change in Serum Insulin-like Growth Factor-1 (IGF-1) From Baseline to 28 Days After Last Dose
Description
IGF-1 is a hormone that manages the effects of growth hormone (GH) in the body. Percent change from Baseline in IGF-1 levels was measured at Day 141. Baseline was defined as the last non-missing value prior to the first administration of Study Drug (ISIS 766720 or placebo). A negative percent change from Baseline indicated improvement. To perform a meaningful assessment of the pharmacodynamic (PD) activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.
Time Frame
Baseline and 28 days after last dose (Day 141)
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
A TEAE was defined as an adverse event that occurred after the initiation of study drug dosing and before the end of the follow-up period.
Time Frame
Up to 211 days
Title
Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings
Description
Vitals signs included blood pressure, heart rate, respiratory rate, and temperature recorded throughout the study. Clinical significance was determined by the investigator.
Time Frame
Up to 211 days
Title
Number of Participants With TEAEs Related to Clinically Significant Physical Examination Findings
Description
Physical examination included weight and body mass index (BMI) recorded throughout the study. Clinical significance was determined by the investigator.
Time Frame
Up to 211 days
Title
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings
Description
Clinical laboratory assessments included clinical chemistry, hematology, and urinalysis. Clinically-significant abnormal laboratory values were reported as TEAEs if the results may, in the opinion of the Investigator, constitute or be associated with an AE.
Time Frame
Up to 211 days
Title
Number of Participants With TEAEs Related to Clinically Significant Electrocardiogram (ECG) Findings
Description
ECG assessments included QT, QRS duration, PR interval, ventricular rate, QTcB, QTcF.
Time Frame
Up to 211 days
Secondary Outcome Measure Information:
Title
Number of Participants Achieving Normalized IGF-1 Levels to Within 1.2 Times of Gender and Age Limits at 28 Days After Last Dose
Description
Normalization of circulating IGF-1 is a validated marker for the treatment of acromegaly. IGF-1 assessments were based on a single serum sample taken in fasting conditions, prior to the study drug administration. Normal IGF-1 levels for a participant differ based on age and gender. Number of participants with a normal IGF-1 level which were 1.2 times within gender and age limits after 28 days of the last dose (Day 141) are presented. To perform a meaningful assessment of the pharmacodynamic activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.
Time Frame
Baseline to 28 days after last dose (Day 141)
Title
Number of Participants Achieving Normalized IGF-1 Levels to Within 1.0 Times of Gender and Age Limits at 28 Days After Last Dose
Description
Normalization of circulating IGF-1 is a validated marker for the treatment of acromegaly. IGF-1 assessments were based on a single serum sample taken in fasting conditions, prior to the study drug administration. Normal IGF-1 levels for a participant differ based on age and gender. Number of participants with a normal IGF-1 level which were 1.0 times within gender and age limits after 28 days of the last dose (Day 141) are presented. To perform a meaningful assessment of the pharmacodynamic activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.
Time Frame
Baseline to 28 days after last dose (Day 141)
Title
Change From Baseline in Serum IGF-1 Over Time
Description
IGF-1 is a hormone that manages the effects of GH in the body. Change from Baseline in IGF-1 levels was measured at multiple timepoints up to Day 211. Baseline was defined as the last non-missing value prior to the first administration of Study Drug (ISIS 766720 or placebo). A negative change from Baseline indicated improvement. To perform a meaningful assessment of the pharmacodynamic activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.
Time Frame
Baseline, Days 15, 29, 43, 57, 71, 85, 99, 112, 127, 141, 155, 183, and 211
Title
Percent Change From Baseline in Serum IGF-1 Over Time
Description
IGF-1 is a hormone that manages the effects of GH in the body. Percent change from Baseline in IGF-1 levels was measured at multiple timepoints up to Day 211. Baseline was defined as the last non-missing value prior to the first administration of Study Drug (ISIS 766720 or placebo). A negative percent change from Baseline indicated improvement. To perform a meaningful assessment of the pharmacodynamic activity of ISIS 766720, the lower dose groups (60 mg and 80 mg) and higher dose groups (120 mg and 160 mg) were combined to achieve group size of 7 or more for PD assessments and these were designated as low-dose and high-dose groups respectively.
Time Frame
Baseline, Days 15, 29, 43, 57, 71, 85, 99, 112, 127, 155, 183, and 211
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females with documented diagnosis of acromegaly, aged 18-75 years old (inclusive) at the time of informed consent
Participants must be on stable maximum or maximally tolerated dose of SRL (Lanreotide Autogel or Octreotide LAR, per treating physician judgment) every 28 days for a minimum of 3 months prior to screening and will be required to continue their stable dose of SRL throughout the study. Prior use of other medications for treating acromegaly is allowed but not within 6 weeks of screening.
At Screening, serum insulin-like growth factor 1 (IGF-1) (performed at central lab) between 1.3 to 5 x upper limit of normal (ULN), inclusive, adjusted for age and sex
Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, abstinent, or using 1 highly effective method of birth control
Exclusion Criteria:
Participants who received surgery for pituitary adenoma within the last 6 months before the trial, or planning to receive surgery during the trial
Participants who received radiotherapy for pituitary adenoma within the last 3 years before the trial, and/or planning to receive radiotherapy during the trial
Participants with pituitary tumor that, per Investigator judgement, is worsening as assessed by pituitary/sellar magnetic resonance imaging (MRI) protocol at Screen or within 6 months of screening
Evidence of decompensated cardiac function per medical judgement and/or New York Heart Association (NYHA) class 3 or 4
Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment
Participants may not have chronic systemic use of glucocorticoids, weight loss medications or participate in weight loss programs within 2 months before randomization and during study participation.
Participants on anti-diabetes medication or estrogen containing medications must be on a stable dose and regimen for >= 3 months prior to screening and throughout the trial
Participants taking glucagon-like peptide 1 (GLP-1) agonists or insulin can be allowed with prior consultation with the Sponsor Medical Monitor
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Palm Research Center, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Palm Research Center, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Oregon Health & Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Magyar Honvedseg Allami Egeszsegugyi Kozpont, II. sz Belgyogyaszat Osztaly
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Szeged University - Szent-Gyorgyi Albert Clinical Center - I. Belgyógyászati Klinika (Internal Medicine)
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos - Hospital of Oncology
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Vaidoto Urbanaviciaus Individuali imone - Endokrinologijos klinika
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
B_Serwis Popenda Sp. J. Specjalistyczna Przychodnia Lekarsk
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
ZIP/Postal Code
40-952
Country
Poland
Facility Name
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o. o.
City
Krakow
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67-00
Country
Poland
Facility Name
Mazowiecki Szpital Brodnowski - Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i Diabetologii
City
Warszawa
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
City
Wroclaw
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Centrul Medical Unirea - Bucuresti, Endocrinologie
City
Bucharest
ZIP/Postal Code
010567
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj - Napoca
City
Cluj-Napoca
ZIP/Postal Code
400349
Country
Romania
Facility Name
Spitalul Clinic Judetean Mures
City
Targu-Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Timisoara
City
Timisoara
ZIP/Postal Code
300723
Country
Romania
Facility Name
Multi-field Medical Clinic Anturium LLC
City
Barnaul
ZIP/Postal Code
656043
Country
Russian Federation
Facility Name
Interregional Clinical Diagnostic Center
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Kuzbass Clinical Hospital n.a. S.V. Belyaev
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Federal State Budget Institution "National Medical Research Center of Endocrinology" of the Ministry of Healthcare of the Russian Federation
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
I.M. Sechenov Moscow First State Medical University
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Novosibirsk State Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Hospital, Endocrinology Department
City
Orenburg
ZIP/Postal Code
460018
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-On-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Almazov National Medical Research Centre
City
St. Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
State Budget Healthcare Institution of the Tver Region
City
Tver
ZIP/Postal Code
170036
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
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