A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly

What Was Tested

The trial (phase 3) is built around Octreotide.

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

SYHX2008.

Sandostatin LAR®.

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 154 participants are expected to be enrolled.

The study will consist of a maximum 4-week screening/Baseline period, followed by 28-week treatment period.

Who Took Part

Enrollment: 154 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Male or female participants aged 18 to 80 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

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

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 2026-05-31 with completion listed for 2029-07-31.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The proportion of patients with an IGF-1 index ≤ 1.0 (time frame: Week 28).

It also tracked 14 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 rate of change in the volume of the pituitary tumor from the baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 154 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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