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New Long-Acting shot takes aim at Acromegaly's hormone overload

NCT ID NCT07814651

Disease control Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Acromegaly is a rare condition where the pituitary gland makes too much growth hormone, causing bones and tissues to enlarge. Researchers are testing a long-acting octreotide injection called SYHX2008 in 78 adults with active acromegaly. Participants receive either the new injection under the skin or the standard Sandostatin LAR injection into muscle for 12 weeks. The trial measures whether the new treatment brings insulin-like growth factor 1 (IGF-1) into the normal range and lowers growth hormone levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a long-acting octreotide injection called SYHX2008
What this could lead to
If it works, this could offer people with acromegaly another long-acting injection option to keep their hormone levels in check.
What could go wrong
This is a mid-stage trial with 78 participants, so it cannot prove long-term safety or that the drug works better than existing options. Octreotide can cause digestive problems and gallbladder issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

78 people

The number who actually took part.

Started

Apr 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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)； 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%

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Conditions

The condition(s) this trial relates to.

acromegaly

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acromegaly

Contacts and locations

Locations

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040, China

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