A Phase 3 interventional study of Debio 4126 and Placebo in Acromegaly, sponsored by Debiopharm International SA. Recruiting at 74 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Debiopharm International SA (part of Debiopharm) · Phase 3, Interventional, and Treatment
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.
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's planned enrollment of 119 is above the median of 43 across 115 interventional studies indexed under Acromegaly.
Browse Acromegaly studies →Debiopharm International SA is the lead sponsor of 51 studies on the registry; 6 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 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.
Drug: Debio 4126 · Drug: Placebo
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).
Drug: Debio 4126
IM injection, a 12-week extended-release formulation of octreotide
IM injection of mannitol suspension
Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN
Time frame: 36 Weeks
Arm C: Percentage of Participants With IGF-1 ≤1x ULN
Time frame: 36 Weeks
Percent Change From Baseline in IGF-1 Values
Time frame: Up to 108 Weeks
Percentage of Participants With IGF-1 ≤1x ULN
Time frame: Up to 108 Weeks
Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL
Time frame: Up to 108 Weeks
Double-blind Period: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to 36 Weeks
Percentage of Participants Who Experienced at Least One TEAE
Time frame: Up to 113 Weeks
Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment
Time frame: Up to 108 Weeks
Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score
Time frame: Up to 108 Weeks
Double-blind Period: Percentage of Participants Taking Rescue Medication
Time frame: Up to 36 Weeks
Trough Plasma Concentration (Ctrough) of Debio 4126
Time frame: Up to 96 Weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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