Not yet recruitingNCT07623824Updated Jun 3, 2026

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly

A Phase 3 interventional study of SYHX2008 and Sandostatin LAR® in Diagnosed With Acromegaly, Currently in the Active Stage of the Disease, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 154
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

he purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in in patients with acromegaly.

Read the 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.

Conditions studied

Diagnosed With Acromegaly, Currently in the Active Stage of the Disease

In context

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 161 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts 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

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 design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 154 participants (estimated)

Study arms

Experimental
SYHX2008
SYHX2008
Drug: SYHX2008
Experimental
Sandostatin LAR®
Sandostatin LAR®
Drug: Sandostatin LAR®

Interventions

DrugSYHX2008
The patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 28 weeks.
DrugSandostatin LAR®
The patients will accept Sandostatin LAR@ by intra-muscular administration.A treatment period of 28 weeks.

What researchers measure

Primary outcomes

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: Week 28

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
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 4、8、12、16、20、24
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
Evaluation of effect on was assessed using Patient Assessed Acromegaly Symptom Question ( PASQ ), an acromegaly-specific quality of life instrument.
Time frame: Weeks 12、28
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 12、28
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
Percentage changes in fasting GH from baseline
Time frame: Weeks 4、8、12、16、20、24、28
Percentage changes in IGF-1 from baseline
Time frame: Weeks 4、8、12、16、20、24、28
Incidence of adverse events (AE)
Proportion of subjects with adverse events (AEs) within Weeks 28
Time frame: From the signing of informed consent up to 28 Weeks after the first dose
The concentration of octreotide
The concentration of octreotide in the plasma of patients with acromegaly after administration of SYHX2008 injection and Sandostatin LAR®
Time frame: From the signing of informed consent up to 28 Weeks afterthe first dose

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07623824
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party: Sponsor
First posted: Jun 3, 2026
Start date: May 31, 2026 (estimated)
Primary completion: Jul 31, 2029 (estimated)
Completion: Dec 30, 2029 (estimated)
Last update: Jun 3, 2026

Study contacts

Clinical Trials Information Group officer

Contact

ctr-contact@cspc.cn

+86311-69085587

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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