Diagnosed With Acromegaly, Currently in the Active Stage of the DiseasePhase 3NCT07623824
A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly
A Phase 3 study testing SYHX2008 and Sandostatin LAR® in people with Diagnosed With Acromegaly, Currently in the Active Stage of the Disease, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
he purpose of this study is to evaluate the efficacy and safety of SYHX2008 injection in in patients with acromegaly. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diagnosed With Acromegaly, Currently in the Active Stage of the Disease
- What is being tested?
- SYHX2008 and Sandostatin LAR®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2026to 30 Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)；
Who cannot join
- 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%
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Parallel, Open-label, Multicenter, Positive-controlled, Superiority Phase III Trial to Evaluate the Efficacy and Safety of Octreotide Long-acting Injection in Patients With Acromegaly
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.
- Being tested
- SYHX2008, Sandostatin LAR®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHX2008Drug
The patients will accept SYHX2008 injection by subcutaneous administration.A treatment period of 28 weeks.
Sandostatin LAR®Drug
The patients will accept Sandostatin LAR@ by intra-muscular administration.A treatment period of 28 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SYHX2008 | Experimental | SYHX2008 Receives: Drug: SYHX2008 |
| Sandostatin LAR® | Experimental | Sandostatin LAR® Receives: Drug: Sandostatin LAR® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: weeks 4、8、12、16、20、24、28
The proportion of patients with fasting GH < 1.0 ng/mL
Measured: Weeks 4、8、12、16、20、24、28
The proportion of patients with fasting GH<2.5 ng/mL
Measured: 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
Measured: Weeks 4、8、12、16、20、24
The rate of change in the volume of the pituitary tumor from the baseline
Measured: 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.
Measured: 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.
Measured: Weeks 12、28
The proportion of patients with fasting GH decreased by ≥50% compared to the baseline
Measured: Weeks 4、8、12、16、20、24、28
The proportion of patients whose IGF-1 index decreased by ≥50% compared with the baseline
Measured: Weeks 4、8、12、16、20、24、28
Percentage changes in fasting GH from baseline
Measured: Weeks 4、8、12、16、20、24、28
Percentage changes in IGF-1 from baseline
Measured: Weeks 4、8、12、16、20、24、28
Incidence of adverse events (AE)
Proportion of subjects with adverse events (AEs) within Weeks 28
Measured: 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®
Measured: From the signing of informed consent up to 28 Weeks afterthe first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start31 May 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosed With Acromegaly, Currently in the Active Stage of the DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, parallel, open-label, multicenter, positive-controlled, superiority-designed Phase III clinical study .
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623824
- Sponsor's protocol ID
- SYHX2008-006
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No