A Phase 2 interventional study of SYHX2008 and Sandostatin LAR in Acromegaly, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 2, Interventional, and Treatment
This trial is a phase II clinical trial to evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of octreotide long-acting injection in patients with acromegaly.
This study is a randomized, parallel-group, multicenter phase II clinical trial to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of long-acting octreotide 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 84 participants are expected to be enrolled. The study will consist of a maximum 4-week screening/Baseline period, followed by 12-week treatment period.
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's enrollment of 78 is above the median of 43 across 115 interventional studies indexed under Acromegaly.
Browse Acromegaly studies →CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 167 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SYHX2008
Drug: Sandostatin LAR
The patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 12 weeks.
The patients will accept Sandostatin LAR by intra-muscular administration.A treatment period of 12 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
Time frame: Weeks 12
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
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
The proportion of patients with fasting GH < 1.0 ng/mL.
Time frame: Weeks 4、8、12
The proportion of patients with fasting GH<2.5 ng/mL
Time frame: Weeks 4、8、12
The proportion of patients with an IGF-1 index ≤ 1.0
Time frame: Weeks 4、8
The proportion of patients with an IGF-1 index < 1.3
Time frame: Weeks 12
The rate of change in the volume of the pituitary tumor from the baseline.
Time frame: Weeks12
The change in the total PASQ score from the baseline.
Evaluation of effect on was assessed using Patient Assessed Acromegaly Symptom Question ( PASQ ), an acromegaly-specific quality of life instrument.
Time frame: Weeks4、8、12
The change in the total AcroQoL score from the baseline
Evaluation of effect was assessed using Acromegaly Quality of Life Questionnaire（AcroQoL）, an acromegaly-specific quality of life instrument.
Time frame: Weeks 4、8、12
The proportion of patients treated with remedial drugs.
Time frame: Weeks 4、8、12
The proportion of patients with fasting GH decreased by ≥50% compared to the baseline.
Time frame: Weeks 4、8、12
The proportion of patients whose IGF-1 index decreased by ≥50% compared with the baseline.
Time frame: Weeks 4、8、12
Ran from Apr 2024 to primary completion in Apr 2026, 23 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SYHX2008
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. →