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NCT Number: NCT07479862

A Study of SA030 Injection in Overweight or Obese Participants

This study is the first time SA030 is being given to people. The goal is to understand how safe it is, how well it is tolerated, and how the body processes and responds to a single dose of SA030 in individuals who are overweight or obese.

Over the last few decades, more and more people around the world have become overweight or obese, and the numbers keep rising in almost every country. From 1990 to 2021, this problem grew steadily and reached its highest point in 2021.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research Pty Ltd North Terrace

Adelaide, 5000, Australia

Location contact

Dr. Thomas Metodey Polasek

CONTACT

[email protected]

0458162715

Dr. Thomas Metodey Polasek

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dose escalation of SA030

Drug

Single dose, 5 dose levels

Matching placebo of SA030

Drug

Arm 2. single dose, matching placebo

Primary outcomes

  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Approximatly 6 months

  2. Number of participants with clinical significant laboratory abnormalities

    Time frame: Approximatly 6 months

Secondary outcomes

  1. Peak plasma concentration (Cmax)

    Time frame: Pre-dose, multiple timepoints post-dose up to Day 5

    Pharmacokinetic parameter

  2. Time to peak plasma concentration (Tmax)

    Time frame: Pre-dose, multiple timepoints post-dose up to Day 5

    Pharmacokinetic parameter

  3. Plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)

    Time frame: Pre-dose, multiple timepoints post-dose up to Day 5

    Pharmacokinetic parameter

  4. Plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)

    Time frame: Pre-dose, multiple timepoints post-dose up to Day 5

    Pharmacokinetic parameter

  5. Elimination half-life (t1/2)

    Time frame: Pre-dose, multiple timepoints post-dose up to Day 5

    Pharmacokinetic parameter

  6. Terminal elimination rate constant (λz)

    Time frame: Pre-dose, multiple timepoints post-dose up to Day 5

    Pharmacokinetic parameter:

  7. Apparent volume of distribution (Vd/F)

    Time frame: Pre-dose, multiple timepoints post-dose up to Day 5

    Pharmacokinetic parameter

  8. Apparent clearance (CL/F)

    Time frame: Pre-dose, multiple timepoints post-dose up to Day 5

    Pharmacokinetic parameter

  9. Number and percentage of participants developing immunogenicity (anti-SA030 antibodies)

    Time frame: Up to 6 months

  10. Changes in weight

    Time frame: baseline, up to 24 weeks

  11. Changes in BMI

    Time frame: baseline, up to 24 weeks

  12. Changes in waist circumference

    Time frame: baseline, up to 24 weeks

  13. Changes in hip circumference,

    Time frame: baseline, up to 24 weeks

  14. Changes in waist-to-hip ratio

    Time frame: baseline, up to 24 weeks

  15. Changes in body fat content

    Time frame: baseline, up to 24 weeks

  16. Changes in ALK7 expression

    Time frame: baseline, up to 24 weeks

  17. Change in QTcF relative to baseline and relative to placebo compared to baseline

    Time frame: From baseline to Day 13

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Thomas Polasek

CONTACT

[email protected]

0458162715

Sponsors and collaborators

Lead sponsor

Suzhou Siran Biotechnology Co.,Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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