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

Conditions

• Acromegaly

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Debio 4126 — DRUG
  IM injection, a 12-week extended-release formulation of octreotide
• Placebo — DRUG
  IM injection of mannitol suspension

Study Details

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.

Key Dates

Start date

Nov 26, 2025

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Mar 31, 2029

Study Design

Enrollment

119 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: 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.
• Placebo Comparator: Arm B: Placebo + 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.
• Experimental: Arm C: Debio 4126 (Open-Label Treatment Period)
  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 Measure

Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN [ Time Frame: 36 Weeks ]

Central Contacts

• Debiopharm International S.A
  +41 21 321 01 11
  [email protected]

Locations (9)

Find similar trials in Los Angeles, CA

Related Studies

• ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly
  PHASE2 · Recruiting · Alexion Pharmaceuticals, Inc. · Los Angeles, California
• Study of MAR002 in Healthy Men
  PHASE1 · Recruiting · Marea Therapeutics · Tempe, Arizona