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NCT Number: NCT07803991

Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes.

To evaluate the efficacy and safety of SYH2069 injection compared with placebo in obese Non-diabetic Participants after 28 weeks of treatment.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1.Male or female participants, 18-65 years of age at the time of signing informed consent;
  • 2.At screening visit, 28.0 kg/m^2≤BMI≤ 40.0 kg/m^2;
  • 3.Maintained consistent diet and exercise habits with stable body weight within the 12 weeks prior to screening (self-reported weight variation <5%).;
  • 4.Able to understand and comply with trial procedures, voluntarily participate in the trial, and provide written informed consent (ICF).

Exclusion criteria

  • 1. Participants with a history of diabetes mellitus or hypoglycemic episodes;
  • 2. Participants with obesity caused by known single-gene mutations, other medical conditions, or medications, or weight gain not resulting from increased adipose tissue mass;
  • 3. Use of any medications or products that alter body weight and interfere with weight assessment within 3 months prior to screening;
  • 4. Prior bariatric surgery or weight-loss interventions, or plan to receive any bariatric surgery or weight-loss intervention during the trial.
  • 5. History of or known hypersensitivity to any active ingredient or excipient of the investigational product; known allergic diathesis; or severe allergic diseases present at screening.
  • 6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
  • 7. Prior history of acute or chronic pancreatitis or pancreatic injury; history of acute gallbladder disease within 1 year prior to screening; .
  • 8. History of severe cardiovascular or cerebrovascular events within 6 months prior to screening.
  • 9. Prior severe respiratory, central nervous system or psychiatric disorders; any suicide attempts within the past 2 years, or suicidal ideation within 3 months prior to screening or during screening;
  • 10. Any treated or untreated malignancy diagnosed from 5 years before screening through randomization (clinically cured basal cell carcinoma or carcinoma in situ are exempted).
  • 11. Clinically significant hematological diseases, hemolytic or red blood cell disorders, or baseline conditions that interfere with HbA1c measurement at screening or randomization.
  • 12. Participants with inadequately controlled blood pressure
  • 13. History of alcohol abuse, substance misuse or illicit drug use prior to screening
  • 14. Severe trauma, severe or acute infection occurring within 3 months prior to screening or between screening and randomization
  • 15. Prior clinical trial exposure to study drug within 90 days pre-screening or 5 drug half-lives, whichever is longer.
  • 16. Pregnancy or lactation; fertile male or female participants and their partners who fail to use effective contraception throughout the trial and for 3 months following the end of treatment.
  • 17. Any other conditions that, in the investigator's judgment, render the participant unsuitable for this study.

Treatment and study plan

SYH2069 Injection

Drug

0.6ml , 1.2ml , administered subcutaneously (SC),Administer the drug according to the clinical trial protocol

SYH2069 Injection placebo

Drug

0.6ml , 1.2ml , SC,Administer the drug according to the clinical trial protocol

Primary outcomes

  1. Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment

    Time frame: 28 weeks

Secondary outcomes

  1. Proportion of subjects with a weight loss of ≥5% , 10%, 15% from baseline at 28 weeks of treatment

    Time frame: Baseline through Week 28

  2. Change from baseline in body Weight

    Time frame: Week 2, 4, 8, 12, 16, 20, 24 and 28

  3. Changes from baseline in waist circumference

    Time frame: Baseline through Week 28

  4. Changes from baseline in hip circumference

    Time frame: Baseline through Week 28

  5. Changes from baseline in waist-to-hip ratio

    Time frame: Baseline through Week 28

  6. Changes from baseline in Body Mass Index (BMI)

    Time frame: Baseline through Week 28

  7. Changes from baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline through Week 28

  8. Changes from baseline in fasting plasma glucose (FPG)

    Time frame: Baseline through Week 28

  9. Changes from baseline in fasting C-peptide

    Time frame: Baseline through Week 28

  10. Changes from baseline in Homeostatic Model Assessment of Insulin Resistance(HOMA-IRs)

    Time frame: Baseline through Week 28

  11. Changes from baseline in systolic blood pressure

    Time frame: Baseline through Week 28

  12. Changes from baseline in diastolic blood pressure

    Time frame: Baseline through Week 28

  13. Changes from baseline in lipid parameters (TC, LDL-C, HDL-C, non-HDL-C, TG, ApoB)

    Time frame: Baseline through Week 28

  14. Changes from baseline in high sensitivity C reactive protein (hs-CRP)

    Time frame: Baseline through Week 28

  15. Changes from baseline in urinary albumin-to-creatinine ratio (UACR)

    Time frame: Baseline through Week 28

  16. The incidence rate of adverse events (AEs)

    Time frame: Baseline through Week 31

  17. Plasma concentrations & PK parameters: Peak Time (Tmax)

    Time frame: Baseline through Week 31

  18. Plasma concentrations & PK parameters: Peak Plasma Concentration (Cmax)

    Time frame: Baseline through Week 31

  19. Plasma concentrations & PK parameters: Area under the plasma concentration versus time curve(AUC) : AUClast, AUC0-168h, AUC0-336h

    Time frame: Baseline through Week 31

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo Parallel-Controlled, Phase II Study to Evaluate the Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2026
Registry last updated
Sep 4, 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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