Not yet recruitingPhase 2

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

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

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Asset

SYH2069

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

360

Study population

Obesity / overweight

Eligibility highlights

•BMI ≤40

Primary endpoint

•Relative percentage change in body weight from baseline at of treatment

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07803991

Org study IDSYH2069-004

Timeline

Milestones

Study start2026-09-01estimated

Study first posted2026-09-04actual

Last update posted2026-09-04actual

Primary completion2027-09-30estimated

Study completion2027-12-31estimated

Assets

Investigational agents

SYH2069

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Renal / kidney

Other (unclassified)

Weight & body composition

6 endpoints

Primary/protocol endpoint

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

Time frame:28 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline through Week 28

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body Weight

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

change from baseline, improvement

Secondary/protocol endpoint

Changes from baseline in waist circumference

Time frame:Baseline through Week 28

descriptive

Secondary/protocol endpoint

Changes from baseline in waist-to-hip ratio

Time frame:Baseline through Week 28

ratio, improvement

Secondary/protocol endpoint

Changes from baseline in Body Mass Index (BMI)

Time frame:Baseline through Week 28

descriptive

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Changes from baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline through Week 28

descriptive

Secondary/protocol endpoint

Changes from baseline in fasting plasma glucose (FPG)

Time frame:Baseline through Week 28

concentration, descriptive

Secondary/protocol endpoint

Changes from baseline in fasting C-peptide

Time frame:Baseline through Week 28

descriptive

Secondary/protocol endpoint

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

Time frame:Baseline through Week 28

descriptive

Renal / kidney

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline through Week 28

ratio, improvement

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Changes from baseline in systolic blood pressure

Time frame:Baseline through Week 28

descriptive

Secondary/protocol endpoint

Changes from baseline in diastolic blood pressure

Time frame:Baseline through Week 28

descriptive

Secondary/protocol endpoint

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

Time frame:Baseline through Week 28

descriptive

Secondary/protocol endpoint

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

Time frame:Baseline through Week 28

descriptive

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

The incidence rate of adverse events (AEs)

Time frame:Baseline through Week 31

descriptive

Secondary/protocol endpoint

Plasma concentrations & PK parameters: Peak Time (Tmax)

Time frame:Baseline through Week 31

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Baseline through Week 31

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Baseline through Week 31

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Changes from baseline in hip circumference

Time frame:Baseline through Week 28

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.