Health Trials

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

ConditionAcromegaly
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDebiopharm International SA

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients ≥18 years of age

Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.

IGF-1 at screening ≤1x ULN

Acromegaly diagnosis, defined as per protocol

Disqualifiers

Compression of optic chiasm causing visual defects

Symptomatic cholelithiasis or bile duct dilatation

Planned cholecystectomy during the trial duration

Acute or chronic pancreatitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Debio 4126

    Drug

    IM injection, a 12-week extended-release formulation of octreotide

  • Placebo

    Drug

    IM injection of mannitol suspension

Treatment groups

119 Participants
are divided into 3 treatment groups
Group A: Arm A: Debio 4126Experimental treatment 1 intervention
Group B: Arm B: Placebo + Debio 4126Placebo comparator 2 interventions
Group C: Arm C: Debio 4126 (Open-Label Treatment Period)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN

Time frame
36 Weeks

Secondary outcomes

1

Arm C: Percentage of Participants With IGF-1 ≤1x ULN

Time frame
36 Weeks
2

Percent Change From Baseline in IGF-1 Values

Time frame
Up to 108 Weeks
3

Percentage of Participants With IGF-1 ≤1x ULN

Time frame
Up to 108 Weeks
4

Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL

Time frame
Up to 108 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Debiopharm International SA

Lead sponsor

Source ClinicalTrials.gov
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