Clinical trial NCT06930625: A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Official title: A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acromegaly
Keywords: IGF-1
Growth hormone
Pituitary gland
Gigantism
Lead sponsor: Debiopharm International SA
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.


Eligibility criteria: Inclusion criteria

1. Patients ≥18 years of age
2. Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
3. IGF-1 at screening ≤1x ULN
4. Acromegaly diagnosis, defined as per protocol
5. Adequate bone marrow, hepatic and renal function
6. To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication
7. Other protocol-defined criteria apply

Exclusion criteria

1. Compression of optic chiasm causing visual defects
2. Symptomatic cholelithiasis or bile duct dilatation
3. Planned cholecystectomy during the trial duration
4. Acute or chronic pancreatitis
5. Pituitary radiotherapy
6. Uncontrolled hypothyroidism
7. Uncontrolled diabetes
8. Pituitary surgery within 6 months before screening or planned on trial
9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening
10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
11. Other protocol-defined criteria apply

Primary outcomes:
measure: Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN
timeFrame: 36 Weeks
Secondary outcomes:
measure: Arm C: Percentage of Participants With IGF-1 ≤1x ULN
timeFrame: 36 Weeks
measure: Percent Change From Baseline in IGF-1 Values
timeFrame: Up to 108 Weeks
measure: Percentage of Participants With IGF-1 ≤1x ULN
timeFrame: Up to 108 Weeks
measure: Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL
timeFrame: Up to 108 Weeks
measure: Double-blind Period: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to 36 Weeks
measure: Percentage of Participants Who Experienced at Least One TEAE
timeFrame: Up to 113 Weeks
measure: Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment
timeFrame: Up to 108 Weeks
measure: Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score
timeFrame: Up to 108 Weeks
measure: Double-blind Period: Percentage of Participants Taking Rescue Medication
timeFrame: Up to 36 Weeks
measure: Trough Plasma Concentration (Ctrough) of Debio 4126
timeFrame: Up to 96 Weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University-School of Medicine
state: Missouri
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References: