AcromegalyPhase 2NCT07814651
A Clinical Trial to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Octreotide Long-acting Injection in Patients With Acromegaly
A Phase 2 study testing SYHX2008 and Sandostatin LAR in people with Acromegaly, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This trial is a phase II clinical trial to evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of octreotide long-acting injection in patients with acromegaly. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromegaly
- 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
- 78 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2024to 23 Apr 2026
- Phase
- Phase 2
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 to 75 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
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: 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.
This trial is a phase II clinical trial to evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of octreotide long-acting injection in patients with acromegaly.
Read the detailed description
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.
- Conditions
- Acromegaly
- Being tested
- SYHX2008, Sandostatin LAR
- Medical subject headings
- Acromegaly
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 12 weeks.
Sandostatin LARDrug
The patients will accept Sandostatin LAR by intra-muscular administration.A treatment period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SYHX2008 | Experimental | Not described Receives: Drug: SYHX2008 |
| Sandostatin LAR | Active comparator | Not described 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: Weeks 12
Secondary outcomes (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
Measured: 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.
Measured: Weeks 4、8、12
The proportion of patients with fasting GH < 1.0 ng/mL.
Measured: Weeks 4、8、12
The proportion of patients with fasting GH<2.5 ng/mL
Measured: Weeks 4、8、12
The proportion of patients with an IGF-1 index ≤ 1.0
Measured: Weeks 4、8
The proportion of patients with an IGF-1 index < 1.3
Measured: Weeks 12
The rate of change in the volume of the pituitary tumor from the baseline.
Measured: 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.
Measured: 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.
Measured: Weeks 4、8、12
The proportion of patients treated with remedial drugs.
Measured: Weeks 4、8、12
The proportion of patients with fasting GH decreased by ≥50% compared to the baseline.
Measured: Weeks 4、8、12
The proportion of patients whose IGF-1 index decreased by ≥50% compared with the baseline.
Measured: Weeks 4、8、12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start16 Apr 2024
- Primary completion9 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
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
- NCT07814651
- Sponsor's protocol ID
- SYHX2008-002
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No