Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

What Was Tested

This registered phase 3 trial tested Lanreotide.

The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

It had 1 arm (groups): 1 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 125 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: The patient must have had documentation supporting the diagnosis of acromegaly, including elevated GH and/or IGF-1 levels.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: the patient has received dopamine agonist within 6 weeks prior to the study entry; the patient has abnormal hepatic function at study entry (defined as ast, alt, ggt, alkaline phosphatase, prothrombin time or total bilirubin above 2 uln); the patient is at risk of pregnancy or is lactating.

How the Study Was Run

Design: single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-10 with completion listed for 2008-10.

It ran at 24 sites in France (5), Germany (3), Italy (3), Spain (3), Czechia (2) and Netherlands (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period (time frame: V3 (Week 12; Baseline) up to V11 (Week 44)). Percentage of Subjects With Acromegaly With a Normalised (Age and Sex Adjusted) IGF-1 Level at the End of the Co-administration Period; Summarised by Diabetic Status at Baseline (time frame: V3 (Week 12; Baseline) up to V11 (Week 44)).

It also tracked 22 secondary outcomes, for example Percentage of Subjects With a Normalised (Age and Sex Adjusted) IGF-1 Level at Any Time During the Co-administration Period, Percentage of Subjects With Normalised (Age and Sex Adjusted) IGF-1 at Each Assessment, Change From Baseline in Serum IGF-1 Levels (Expressed as Z-scores) During the Co-administration Period, Change From Baseline in Acromegaly Symptoms During the Co-administration Period, Change From Baseline in Acromegaly Quality of Life (ACROQoL) Assessments During the Co-administration Period and Change From Baseline in Mean Weight From Baseline During the Co-administration Period.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Lanreotide in 125 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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