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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acromegaly

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving full biochemical control | Defined as fasting Growth Hormone (GH) ≤ 2.5 μg/L and Insulin-like Growth Factor-1 (IGF-1) normalization | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving fasting GH < 1 μg/L and IGF-1 normalization |  | At 12 months | 
| Percentage of participants achieving fasting GH ≤2.5 μg/L and IGF-1 ≤1.3 Upper Limit of Normal (ULN) |  | At 12 months | 
| Mean change in fasting GH and IGF-1 concentrations. |  | From baseline to 3, 6, and 12 months | 
| 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. |  | From baseline to 6 and 12 months | 
| Mean change in Quality of Life (QoL) scores | Assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL). | From baseline to 6 and 12 months | 
| Treatment utilisation of LAN, evaluated by the total number of injections received |  | From baseline to 12 months | 
| Treatment utilisation of LAN, evaluated by number of participants in Extended Dosing Interval (EDI) |  | From baseline to 12 months | 
| Incidence of all Adverse Events (AEs) | Including Serious Adverse Events (SAEs) and special situations assessed according to incidence, intensity, causality, outcome, action taken, and seriousness. | From baseline to 3, 6 and 12 months | 
| Mean change in physical examination results | Including Body Mass Index (BMI) and weight | From baseline to 3, 6, and 12 months | 
| Mean change in vital signs blood pressure |  | From baseline to 3, 6, and 12 months | 
| Mean change in vital signs heart rate |  | From baseline to 3, 6, and 12 months | 
| Mean change in Clinical laboratory assessments | Including fasting blood glucose, glycated hemoglobin A1C (HbA1c), total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL, and triglycerides | From baseline to 6, and 12 months | 
| Mean change in free thyroxine (FT4) and cortisol for males and females |  | From baseline to 6 and 12 months | 
| Mean change in testosterone for males only |  | From baseline to 6 and 12 months | 
| Mean change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol for females only. |  | From baseline to 6 and 12 months |