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WithdrawnNCT00517491Updated Aug 5, 2019

Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

A Phase 2 interventional study of lanreotide (Autogel formulation) in Acromegaly, sponsored by Ipsen. Withdrawn at 1 site in Mexico. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-08-05.

Sponsored by Ipsen · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Administrative reasons
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)

02

Conditions studied

  • Acromegaly

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03

In context

Acromegaly

196 studies on the registry are indexed under Acromegaly; 18 are open to participants now.

Browse Acromegaly studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient on treatment with octreotide LAR 20 mg administered every 28 days for at least 3 months prior to visit 1.
  • Patient must have serum GH level ≤ 2.5 ng/mL and serum IGF-1 ≤ 1.3 ULN, 28 days after their last injection of octreotide LAR 20 mg at visit 1.
  • Patients must have serum GH level > 2.5 ng/mL AND serum IGF-1 level > 1.3 ULN, 6 or 8 weeks after their last injection of octreotide LAR 20 mg.

Exclusion criteria

Exclusion Criteria:

  • The patient has received pituitary radiation therapy of any kind at any time prior to visit 1.
  • The patient has received pituitary surgery within 3 months prior to visit 1.
  • The patient's serum creatinine is higher than 150 µmol/l.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    Drug: lanreotide (Autogel formulation)

Interventions

  • Druglanreotide (Autogel formulation)

    120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study.

06

What researchers measure

Primary outcomes

  1. GH (basal and during Oral Glucose Tolerance Test (OGTT)) and IGF-1 levels, in acromegalic patients previously treated with octreotide long acting release (LAR) 20 mg.

    Time frame: Weeks 16, 18 & 20

  2. Acromegaly symptoms.

    Time frame: Weeks 16, 18 & 20

  3. Indices of insulin secretion & sensitivity

    Time frame: Weeks 16, 18 & 20

  4. Adverse events

    Time frame: Throughout study

Secondary outcomes

  1. Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN).

    Time frame: Weeks 16, 18 & 20.

  2. Serum lanreotide Autogel 120 mg concentrations.

    Time frame: Weeks 16, 18 & 20.

  3. ECG and gallbladder ultrasound

    Time frame: Week 20

07

Study locations

1 site
  • Centro Médico Nacional Siglo XXI, IMSS
    Mexico City, 06720, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00517491
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Aug 17, 2007
Start date
May 2008
Primary completion
Dec 2008 (estimated)
Completion
Dec 2008 (estimated)
Last update
Aug 5, 2019

Study contacts

Ipsen Medical Director
study director · Ipsen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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