A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs

Phase 3

Recruiting

• Conditions: Acromegaly
• Interventions: Drug: Debio 4126; Drug: Placebo

• Registration Number: NCT06930625
• Lead Sponsor: Debiopharm International SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Study First Posted: 2025-04-16
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Last Update Submitted: 2025-07-29
• Last Update Posted: 2025-07-30
• Primary Completion: 2028-06
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Debio 4126	Debio 4126	During Period 1 (double-blind treatment period), participants will receive an intramuscular (IM) injection of Debio 4126 once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication. Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
Arm B: Placebo + Debio 4126	Debio 4126	During Period 1 (double-blind treatment period), participants will receive an IM injection of placebo once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication. Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
Arm B: Placebo + Debio 4126	Placebo	During Period 1 (double-blind treatment period), participants will receive an IM injection of placebo once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication. Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
Arm C: Debio 4126 (Open-Label Treatment Period)	Debio 4126	During the Treatment Period, participants will receive an IM injection of Debio 4126 once every 12 weeks over a total of between 60 and 96 weeks (between 5 and 8 injections in total).

Primary Outcome Measures

Name	Time	Method
Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN	36 Weeks

Secondary Outcome Measures

Name	Time	Method
Trough Plasma Concentration (Ctrough) of Debio 4126	Up to 96 Weeks
Arm C: Percentage of Participants With IGF-1 ≤1x ULN	36 Weeks
Percent Change From Baseline in IGF-1 Values	Up to 108 Weeks
Percentage of Participants With IGF-1 ≤1x ULN	Up to 108 Weeks
Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL	Up to 108 Weeks
Double-blind Period: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)	Up to 36 Weeks
Percentage of Participants Who Experienced at Least One TEAE	Up to 113 Weeks
Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment	Up to 108 Weeks
Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score	Up to 108 Weeks
Double-blind Period: Percentage of Participants Taking Rescue Medication	Up to 36 Weeks

Trial Locations

Locations (16)

Harvard Medical School; 🇺🇸 Boston, Massachusetts, United States

Medical University Graz; 🇦🇹 Graz, Austria

UZ Gent; 🇧🇪 Gent, Belgium

East Tallinn Central Hospital; 🇪🇪 Tallinn, Estonia

North Estonia Medical Centre Foundation; 🇪🇪 Tallinn, Estonia

Azienda ospedaliero Universitaria di Ferrara; 🇮🇹 Ferrara, Italy

Ospedale Policlinico San Martino IRCCS; 🇮🇹 Genova, Italy

Centrum Medyczne Intercor Sp. z o.o.; 🇵🇱 Bydgoszcz, Poland

Delta Health Care; 🇷🇴 Bucharest, Romania

University Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

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