DRUG
SYHX2008
The patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 28 weeks.
A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly
Status
Not yet recruiting
Phase
Phase 3
Enrollment
154
Locations
0
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
he purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in in patients with acromegaly.
Full detailed description
This study is a randomized, parallel, open-label, multicenter, positive-controlled, superiority-designed Phase III clinical study evaluating the efficacy and safety of octreotide long-acting injection in patients with acromegaly. The purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in treating acromegaly. Patients will be randomized to SYHX2008 cohort or Octreotide Microspheres(Sandostatin LAR®) cohort. A total of 154 participants are expected to be enrolled. The study will consist of a maximum 4-week screening/Baseline period, followed by 28-week treatment period.
Interventions
Treatment arms and agents.
DRUG
Sandostatin LAR®
The patients will accept Sandostatin LAR@ by intra-muscular administration.A treatment period of 28 weeks.
Timeline
From registration to results.
First posted
Jun 3, 2026
Study start
May 31, 2026
Primary completion
Jul 31, 2029
Study completion
Dec 30, 2029
Results posted
Not reported
Registry updated
Jun 3, 2026
Outcomes
What the study measures.
Primary outcomes
The proportion of patients with an IGF-1 index ≤ 1.0
Time frame · Week 28
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
Secondary outcomes
The proportion of patients with fasting GH less than 2.5 ng/mL and IGF-1 index less than or equal to 1.0
Time frame · weeks 4、8、12、16、20、24、28
The proportion of patients with GH less than 1.0 ng/mL and IGF-1 index less than or equal to 1.0
Time frame · weeks 4、8、12、16、20、24、28
The proportion of patients with fasting GH < 1.0 ng/mL
Time frame · Weeks 4、8、12、16、20、24、28
The proportion of patients with fasting GH<2.5 ng/mL
Time frame · Weeks 4、8、12、16、20、24、28
The proportion of patients with an IGF-1 index ≤ 1.0
Time frame · Weeks 4、8、12、16、20、24
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 rate of change in the volume of the pituitary tumor from the baseline
Time frame · Weeks 28
The change in the total PASQ score from the baseline
Time frame · Weeks 12、28
Evaluation of effect on was assessed using Patient Assessed Acromegaly Symptom Question ( PASQ ), an acromegaly-specific quality of life instrument.
The change in the total AcroQoL score from the baseline
Time frame · Weeks 12、28
Evaluation of effect was assessed using Acromegaly Quality of Life Questionnaire（AcroQoL）, an acromegaly-specific quality of life instrument.
The proportion of patients with fasting GH decreased by ≥50% compared to the baseline
Time frame · Weeks 4、8、12、16、20、24、28
The proportion of patients whose IGF-1 index decreased by ≥50% compared with the baseline
Time frame · Weeks 4、8、12、16、20、24、28
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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)； Exclusion Criteria: * 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. * Participants with obvious visual field defects caused by optic chiasm compression and requiring surgical intervention * HbA1c\>8.5%
Study locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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