he purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in in patients with acromegaly.
Male or female participants aged 18 to 80 years (including boundary values)
Diagnosed with acromegaly, currently in the active stage of the disease (for patients who have not undergone pituitary tumor surgery before, MRI shows a pituitary mass, fasting GH ≥ 2.5 ng/mL and IGF-1 index ≥ 1.3; for patients who have undergone pituitary tumor surgery, fasting GH ≥ 2.5 ng/mL and IGF-1 index ≥ 1.3)；
Have received pituitary radiotherapy within the 5 years prior to screening
Have undergone major surgery (including pituitary surgery) within 6 months prior to screening or are expected to require surgery (including pituitary surgery) or radiotherapy during the study period
Within three months before the screening, participants received drugs such as long-acting lanretide, long-acting octreotide, pervesomone, and cabergoline, or traditional Chinese medicines for treating acromegaly. Receive bromocriptine within one month before screening; Received short-acting octreotide or lanretide short-acting preparations for treatment within 7 days before screening; Or have received any other investigational drug within 30 days before screening or within 5 half-lives (whichever is longer)
Previous failure to respond to octreotide or lantreotide monotherapy (defined as: after at least 3 months of treatment with octreotide microspheres ≥30 mg or lantreotide ≥120 mg, or after at least 3 months of treatment with parietide microspheres ≥40 mg, random GH ≥2.5 ng/mL and/or IGF-1 index ≥1.3) or history of intolerance.
Parallel
SYHX2008
DrugThe patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 28 weeks.
Sandostatin LAR®
DrugThe patients will accept Sandostatin LAR@ by intra-muscular administration.A treatment period of 28 weeks.
The proportion of patients with an IGF-1 index ≤ 1.0
insulin-like growth factor-1 within the normal range after adjustment for age and gender, where IGF-1 index = IGF-1 value/ULN, and ULN is the upper limit of the normal reference range
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
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This trial is not recruiting at the moment. You can still explore other options:
