SA030 Injection in Adults with Overweight or Obesity (Phase 1)
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SA030 Injection in Overweight or Obese Participants
Run by Suzhou Siran Biotechnology Co.,Ltd. · NCT07479862 · Data updated 2026-11-12
This first-in-human study tests a single dose of SA030 to see if it is safe and well tolerated in adults who are overweight or obese.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Suzhou Siran Biotechnology Co.,Ltd. Industry-sponsored |
| Locations | 2 sites (Brisbane, Queensland and 1 other locations) |
| Status | Recruiting |
| Started | April 16, 2026 |
| Main results expected | April 24, 2028 |
| Study ends | April 24, 2028 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07479862 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-55 with BMI 25-40 kg/m2 who are generally healthy and willing to use contraception as required.
✕Probably not a fit
Participants with serious health issues or those who do not meet safety criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, first-in-human trial evaluates a single dose of SA030 versus placebo in adults with BMI 25-40 kg/m2. Participants will undergo screening, receive SA030 or matching placebo, and be monitored for safety, tolerability, pharmacokinetics, and early pharmacodynamic effects. The study aims to establish initial safety data and how the body handles SA030 in this population. Enrollment is limited to adults 18-55 who are generally healthy and meet obesity-related criteria, with contraception requirements for those who can become pregnant.
Why it matters
Potential benefit: If successful, SA030 could advance understanding of its safety in overweight and obese individuals and inform future dosing studies.
How similar studies have gone: Early-phase studies of similar approaches have shown that initial safety and pharmacokinetics can be established in modestly sized cohorts, though this exact formulation is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * You must be able to understand the study and sign a written consent form. * Men or women aged 18 to 55 years can join * Overweight or obese with a body mass index (BMI) between 25-40 kg/m\^2(inclusive); * You should be generally healthy, The study doctor will check your medical history, vital signs, physical exam, blood and urine tests, Electrocardiogram, and abdominal. ultrasound. Minor issues are okay if the doctor thinks they are not medically important. * For female participants of childbearing potential: must be non-pregnant and non- lactating, and agree to use highly effective contraception throughout the study period; * For male participants of reproductive potential: must agree to use highly effective contraception during the study period to ensure effective contraception for sexual partners. Exclusion Criteria: * You cannot join if you have lost or gained more than 5 percent of your body weight in the last 3 months. * You cannot participate if you previously had, or plan to have, weight-loss surgery or a weight-loss device during the study, except for the following procedures done more than 1 year before screening * Use of any over-the-counter medications, herbal supplements, or health products that may significantly affect weight or metabolism within 1 month prior to screening (e.g., orlistat, garcinia cambogia, ephedrine, etc.) * At screening, sitting systolic blood pressure more than of equals to 160 milli meters of mercury and/or diastolic blood pressure more than of equals to 100 mmHg, and deemed unsuitable for participation in this study by the investigator; * Severe psychiatric disorders or uncontrolled psychiatric conditions, including but not limited to schizophrenia, bipolar disorder, or depression, deemed unsuitable for participation in this study by the investigator; * If the screening ECG shows a prolonged QT/QTc interval, and a repeat test confirms QTcF greater than 450 ms in males or greater than 470 ms in females, the participant will be excluded * Suffering from severe diseases, including but not limited to disorders of the nervous system, cardiovascular system, hematopoietic and lymphatic system, immune system, digestive system, urinary system, respiratory system, endocrine system, and history of malignancies, which the investigator judges may compromise safety or influence study results; * Co-infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis; or prior diagnosis of hepatitis A, D, or E without resolution; * Individuals who received a vaccine or live attenuated vaccine within 1 month prior to dosing, or who plan to receive a vaccine during the trial period; Major surgery within 6 months prior to screening, or planned surgery during the study period; * Severe infection or trauma within 4 weeks prior to screening; * Non-physiological blood loss more than or equals 200 milliliter within 1 month prior to study drug administration (including trauma, blood collection, or blood donation), or individuals planning to donate blood during the study period or within 60 days after dosing; * History of severe intolerance to subcutaneous injections (mild reactions such as local swelling or redness are permissible); * Individuals who have taken any prescription medication, herbal supplements, or over-the-counter drugs within 14 days prior to study drug administration; * Participation in other drug clinical trials within 3 months of this study's treatment initiation, or within 5 half-lives of other investigational drug exposure, or participation in siRNA or antisense oligonucleotide drug clinical trials within 6 months prior to this study's treatment initiation (participants who withdrew from the study before receiving the investigational drug may be eligible for this study); * Individuals who smoked more than 5 cigarettes or an equivalent amount of tobacco daily within 3 months prior to screening, or who are unable to abstain from smoking during the trial hospitalization period; * Weekly alcohol consumption exceeding 14 units within 3 months prior to screening (1 unit of alcohol ≈360 milli Liter beer or 45 milli Liter 40 percent alcohol spirits or 150 milli Liter wine), or those with a positive breath alcohol test on the day before dosing (breath alcohol content more than 0.0 milligram per100 mL), or those unable to abstain from alcohol during the trial hospitalization period; * Current or former drug users/substance abusers, or those with a positive urine drug screen on the day before dosing; * Other factors deemed unsuitable for trial participation by the investigator, such as potential for poor compliance.
Where it's running
-
Nucleus Network
Brisbane, Queensland, Australia Recruiting -
CMAX Clinical Research Pty Ltd North Terrace
Adelaide, Australia Recruiting
Study contacts
- Study coordinator: Feifei Zhao
- Email: zhaofeifei@siranbio.com
- Phone: 86-051265295926
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.