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Antisense Oligonucleotide

IONIS-GHR-LRx for Acromegaly

Phase 2
Waitlist Available
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 80 weeks
Awards & highlights

Study Summary

This trial will test a new drug to see if it is safe and effective in treating acromegaly, a condition characterized by too much growth hormone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 80 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 80 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in Insulin-like Growth Factor I (IGF-1) to Week 27
Secondary outcome measures
Change From Baseline in Serum IGF-1 Over Time
Percent Change From Baseline in Serum IGF-1 Over Time
Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.0 Times of Gender and Age Limits at Day 183 (Week 27)
+1 more

Side effects data

From 2021 Phase 2 trial • 43 Patients • NCT03548415
18%
Abdominal pain
18%
Injection site erythema
18%
Headache
18%
Blood creatine phosphokinase increased
9%
Gastrointestinal bacterial infection
9%
Periodontitis
9%
Bundle branch block
9%
Vomiting
9%
Somnolence
9%
Hypertension
9%
Arthralgia
9%
Urinary tract infection
9%
Nausea
9%
Constipation
9%
Wound
9%
Diarrhoea
9%
Chest pain
9%
Fatigue
9%
Limb injury
9%
Pharyngitis
9%
Frequent bowel movements
9%
Urine protein/creatinine ratio increased
9%
Cough
9%
Rhinorrhoea
9%
Thrombophlebitis
9%
Meniscus injury
9%
Muscle strain
9%
Albuminuria
9%
Nephrolithiasis
9%
Enterovirus infection
9%
Glucose tolerance impaired
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B: IONIS GHR-LRx, 80 mg
Cohort D: IONIS GHR-LRx, 160 mg
Placebo
Cohort A: IONIS GHR-LRx, 60 mg
Cohort C: IONIS GHR-LRx, 120 mg

Trial Design

3Treatment groups
Experimental Treatment
Group I: IONIS-GHR-LRx Dose 3Experimental Treatment1 Intervention
Single dose of IONIS-GHR-LRx Dose 3 will be administered by SC injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3).
Group II: IONIS-GHR-LRx Dose 2Experimental Treatment1 Intervention
Single dose of IONIS-GHR-LRx Dose 2 will be administered by SC injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3).
Group III: IONIS-GHR-LRx Dose 1Experimental Treatment1 Intervention
Single dose of IONIS-GHR-LRx Dose 1 will be administered by SC injection once every month for 73 weeks with a booster dose administered on Day 15 (Week 3).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IONIS-GHR-LRx
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
145 Previous Clinical Trials
15,248 Total Patients Enrolled
2 Trials studying Acromegaly
82 Patients Enrolled for Acromegaly

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include patients that are over 55 years old?

"The age restrictions for this trial are 18-75. If a patient does not meet that criterion, there are other options available: 1 clinical trial for people under 18 and 13 for those over 65."

Answered by AI

Is this research project taking place at several hospitals in our state?

"To make things more convenient for enrollees, this trial is being conducted at 7 sites which are situated near large cities like New york and Columbus. There are also other locations spread out across the country."

Answered by AI

What is the status of IONIS-GHR-LRx in regards to government approval?

"While Phase 2 trials offer less data than later stages of testing, IONIS-GHR-LRx's safety was still rated a 2."

Answered by AI

Are recruitment efforts for this clinical trial still underway?

"This study, which was first made public on January 4th 2021 and last updated on August 4th 2022, is not recruiting patients at this time. Although, there are 14 other clinical trials that are currently enrolling participants."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Endocrinology Associates, Inc
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly
2021. "A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04522180.
~8 spots leftby Apr 2025
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