A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

What Was Tested

This registered phase 1 trial tested Octreotide and Lanreotide.

It had two arms (groups): Cohort A: Participants With Acromegaly (experimental) and Cohort B: Participants With GEP-NET (experimental).

Participants will receive Sandostatin Long-acting repeatable (LAR) or Somatuline Autogel (ATG) (or equivalent formulations of octreotide/lanreotide) in Run-in Period and further will receive Debio 4126 in this group.

Participants will receive Sandostatin LAR or Somatuline ATG (or equivalent formulations of octreotide/lanreotide) in Run-in Period and further will receive Debio 4126 in this group.

The registry classes the interventions as drug.

Who Took Part

The registry lists 19 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly will be carried out. IGF-1 ≤1.3 x upper limit of normal (ULN) assessed centrally at screening.

The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: known ongoing gallbladder or bile duct disease or acute or chronic pancreatitis; hypothyroidism not adequately treated with thyroid hormone replacement therapy; new york heart association class ≥3 heart failure.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Octreotide group and the comparison group ran side by side rather than switching.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-05-18 with completion listed for 2024-10-29.

It ran at 14 sites in France (3), Israel (2), Poland (2), Spain (2), United Kingdom (2) and Denmark (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Plasma Concentration of Debio 4126 in Acromegaly and GEP-NET Participants (time frame: Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337).

It also tracked 5 secondary outcomes, for example Insulin-Like Growth Factor 1 (IGF-1) and Growth Hormone (GH) Levels in Acromegaly Participants and Number of Participants With Carcinoid Syndrome Symptoms and use of Rescue Medication for Symptom Control in GEP-NET Participants.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Octreotide and Lanreotide in 19 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page and the Lanreotide compound page, all human trials.