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

NCT07623824 | Not Yet Recruiting Phase 3

• 1 other identifier: SYHX2008-006
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  Week 28

Secondary Outcomes (14)

• The proportion of patients with fasting GH less than 2.5 ng/mL and IGF-1 index less than or equal to 1.0

  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

  weeks 4、8、12、16、20、24、28

• The proportion of patients with fasting GH < 1.0 ng/mL

  Weeks 4、8、12、16、20、24、28

• The proportion of patients with fasting GH<2.5 ng/mL

  Weeks 4、8、12、16、20、24、28

• The proportion of patients with an IGF-1 index ≤ 1.0

  Weeks 4、8、12、16、20、24

Study Arms (2)

SYHX2008

EXPERIMENTAL

SYHX2008

Drug: SYHX2008

Sandostatin LAR®

EXPERIMENTAL

Sandostatin LAR®

Drug: Sandostatin LAR®

Interventions

SYHX2008 DRUG

The patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 28 weeks.

SYHX2008

Sandostatin LAR® DRUG

The patients will accept Sandostatin LAR@ by intra-muscular administration.A treatment period of 28 weeks.

Sandostatin LAR®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)；

You may not qualify if:

• 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%

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

+86311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a randomized, parallel, open-label, multicenter, positive-controlled, superiority-designed Phase III clinical study .

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share