Skip to main content
OpenTrials
Completed

NCT Number: NCT05431803

Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China

This study aims to assess the one-year effectiveness and safety of LAN among patients with acromegaly in China in routine clinical practice. In addition, the study is designed to understand the real-world treatment patterns and outcomes of LAN among Chinese patients with acromegaly.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital (PUMCH), Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who are able to comply with the protocol
  • Participants with serum IGF-1 level above the ULN for age and sex, and serum fasting GH level above 2.5 μg/L
  • Participants with acromegaly who are naïve to LAN treatment and about to initiate LAN

Exclusion criteria

  • Participants who are currently participating in any investigational study or clinical trial of acromegaly
  • Pregnant participants
  • Participants with hypersensitivity to somatostatin or related peptides or to any of the excipients

Treatment and study plan

Primary outcomes

  1. Percentage of participants achieving full biochemical control

    Time frame: At 12 months

    Defined as fasting Growth Hormone (GH) ≤ 2.5 μg/L and Insulin-like Growth Factor-1 (IGF-1) normalization

Secondary outcomes

  1. Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization

    Time frame: At 12 months

  2. Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN)

    Time frame: At 12 months

  3. Mean change in fasting GH and IGF-1 concentrations.

    Time frame: From baseline to 3, 6, and 12 months

  4. Mean change in the proportion of patients experiencing each of the symptoms (headache, excessive sweating, joint pain, fatigue, and soft tissue swelling) as evaluated by physicians.

    Time frame: From baseline to 6 and 12 months

  5. Mean change in Quality of Life (QoL) scores

    Time frame: From baseline to 6 and 12 months

    Assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL).

  6. Treatment utilisation of LAN, evaluated by the total number of injections received

    Time frame: From baseline to 12 months

  7. Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI)

    Time frame: From baseline to 12 months

  8. Incidence of all Adverse Events (AEs)

    Time frame: From baseline to 3, 6 and 12 months

    Including Serious Adverse Events (SAEs) and special situations assessed according to incidence, intensity, causality, outcome, action taken, and seriousness.

  9. Mean change in physical examination results

    Time frame: From baseline to 3, 6, and 12 months

    Including Body Mass Index (BMI) and weight

  10. Mean change in vital signs blood pressure

    Time frame: From baseline to 3, 6, and 12 months

  11. Mean change in vital signs heart rate

    Time frame: From baseline to 3, 6, and 12 months

  12. Mean change in Clinical laboratory assessments

    Time frame: From baseline to 6, and 12 months

    Including fasting blood glucose, glycated hemoglobin A1C (HbA1c), total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL, and triglycerides

  13. Mean change in free thyroxine (FT4) and cortisol for males and females

    Time frame: From baseline to 6 and 12 months

  14. Mean change in testosterone for males only

    Time frame: From baseline to 6 and 12 months

  15. Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only.

    Time frame: From baseline to 6 and 12 months

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Real-World Study of Lanreotide Autogel for the Treatment of Patients With Acromegaly in China

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2022
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.