A Clinical Trial to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Octreotide Long-acting Injection in Patients With Acromegaly

What Was Tested

In this phase 2 trial, researchers set out to test Octreotide.

It had two arms (groups): SYHX2008 (experimental) and Sandostatin LAR (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patients will be randomized to SYHX2008 cohort or Octreotide Microspheres(Sandostatin LAR®) cohort.

A total of 84 participants are expected to be enrolled.

The study will consist of a maximum 4-week screening/Baseline period, followed by 12-week treatment period.

Who Took Part

Enrollment: 78 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female participants aged 18 to 75 years (including boundary values).

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: have received pituitary radiotherapy within the 5 years prior to screening; participants with obvious visual field defects caused by optic chiasm compression and requiring surgical intervention.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Octreotide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2024-04-16 with completion listed for 2026-04-09.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The proportion of patients with an IGF-1 index ≤ 1.0 (time frame: Weeks 12).

It also tracked 12 secondary outcomes, for example The proportion of patients with fasting GH less than 2.5 ng/mL and IGF-1 index less than or equal to 1.0, The proportion of patients with GH less than 1.0 ng/mL and IGF-1 index less than or equal to 1.0, The proportion of patients with fasting GH < 1.0 ng/mL, The proportion of patients with fasting GH<2.5 ng/mL, The proportion of patients with an IGF-1 index ≤ 1.0 and The proportion of patients with an IGF-1 index < 1.3.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 78 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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