Active not recruitingPhase 1

A Study of SYH2069 Injection in Healthy Participants

A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of SYH2069 Injection in Healthy Participants

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Asset

SYH2069

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Actual enrollment

104

Study population

Diabetes (other / unspecified), Obesity / overweight

Eligibility highlights

•BMI 19-28

Primary endpoint

•Treatment-related adverse events as accessed by CTCAE v6.0

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 IDNCT07736391

Org study IDSYH2069-001

Timeline

Milestones

Study start2026-01-10actual

Study first posted2026-07-30actual

Primary completion2026-07-30estimated

Last update posted2026-07-30actual

Study completion2026-11-30estimated

Assets

Investigational agents

SYH2069

Who this study enrolls

Diabetes (other / unspecified)Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Fully understand the content, process and possible adverse reactions of the trial, and voluntarily sign the informed consent form before the trial;

•Male or female, aged 18-55 years (inclusive, based on the time of signing the informed consent form) at screening;

•At screening, male body weight ≥ 50 kg, female body weight ≥ 45 kg, SAD study: BMI between 19 and 28 kg/m2 inclusive), MAD study: BMI between 24 and 35 kg/m 2 inclusive);

•Subjects (including partners) have no plans to have children from the time of signing the informed consent form until 6 months after the last dose, and agree to use highly effective contraceptive measures specified in the protocol.

Exclusion criteria

•Known or suspected allergies to GLP-1 or GIP receptor agonists or any components of the investigational product, or allergic constitution (allergies to multiple drugs and foods);

•Abnormal results of vital signs, physical examination, laboratory tests, chest X-ray, ultrasound, and electrocardiogram, etc., which are judged by the investigator to be clinically significant and unsuitable for participation in the study. Among them, the following conditions were not excluded in the MAD study: (1) systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg; (2) TG ≤ 3.42 mmol/L, TC ≤ 7.75 mmol/L (regardless of whether LDLC is abnormal), and abnormal HDLC; (3) ALT < 2 times × upper limit of normal, AST < 2 times × upper limit of normal, GGT < 2.5 times × upper limit of normal, total bilirubin < 1.5 times × upper limit of normal; (4) Blood uric acid <480 μmol/L and never accompanied by physiological abnormalities (gout, etc.); (5) Ultrasound shows fatty liver and excludes causes other than metabolism;

•Meet any of the following at screening: (1) HbA1c > upper limit of normal, or fasting blood glucose ≤ 3.9 mmol/L or ≥ 6.1 mmol/L; (2) Calcitonin ≥ 50 ng/L; (3) eGFR < 90 mL/min/1.73m 2; (4) TSH exceeds the normal reference range;

•Patients with prolonged QT/QTc interval at screening (QTcF > 450 ms), or have a history of risk factors for torsades de pointes (such as family history of heart failure/cardiomyopathy or long QT syndrome), or are taking concomitant medications that prolong the QT/QTc interval;

•Those who are positive for any of hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum antibody;

•History or presence of major cardiovascular, respiratory, digestive, urinary, hematological, endocrine, immune or nervous system diseases;

•Subjects with severe trauma or major surgery within 6 months prior to screening, or planned to undergo surgery during the trial;

•Patients with thyroid nodules diagnosed as C-TIRADS category 3 or above in the past or during the screening period;

•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2, or history of pancreatitis or acute or chronic gallbladder disease;

•Those with a history of malignant tumors, mental illness, depression, anxiety, or epilepsy;

•History of clinical gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcer);

•Previous gastrointestinal surgery leading to malabsorption, or long-term use of drugs that have a direct effect on gastrointestinal motility. e.g., bariatric surgery or procedures (e.g., gastric banding), or use of GLP-1 or GIP receptor agonists or drugs or products that, in the opinion of the investigator, may cause weight change and affect weight assessment within 3 months prior to dosing.

•Body weight change ≥ 5% within 3 months prior to screening (inclusive) (only applicable to MAD study；

•Those who have symptoms such as dermatitis or skin abnormalities at and around the administration site;

•Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 2 weeks before screening;

•Use of drugs that may affect glucose metabolism (e.g., systemic steroids, non-selective beta-blockers, monoamine oxidase inhibitors) within 1 month before screening;

Endpoints (26)

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

Safety / tolerability / PK

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

Other (unclassified)

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change in body weight from baseline

Time frame:MAD: Baseline up to Day 50

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference from baseline

Time frame:MAD: Baseline up to Day 50

change from baseline, improvement

Secondary/protocol endpoint

Change in Visceral Fat from baseline via Bioelectrical Impedance Analysis (BIA)

Time frame:MAD: Baseline up to Day 29

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Mean change in plasma glucose from baseline

Time frame:SAD: Baseline up to Day 29 MAD: Baseline up to Day 50

change from baseline, improvement

Secondary/protocol endpoint

Mean change in insulin from baseline

Time frame:SAD: Baseline up to Day 29 MAD: Baseline up to Day 50

change from baseline, improvement

Secondary/protocol endpoint

Mean change in C-peptide from baseline

Time frame:SAD: Baseline up to Day 29 MAD: Baseline up to Day 50

change from baseline, improvement

Secondary/protocol endpoint

Mean change in HbA1c from baseline

Time frame:MAD: Baseline up to Day 50

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Mean change in Total Cholesterol(TC) from baseline

Time frame:MAD: Baseline up to Day 29

change from baseline, improvement

Secondary/protocol endpoint

Mean change in Triglycerides(TG) from baseline

Time frame:MAD: Baseline up to Day 29

change from baseline, improvement

Secondary/protocol endpoint

Mean change in Low-Density Lipoprotein Cholesterol(LDLC) from baseline

Time frame:MAD: Baseline up to Day 29

change from baseline, improvement

Secondary/protocol endpoint

Mean change in High-Density Lipoprotein Cholesterol(HDLC) from baseline

Time frame:MAD: Baseline up to Day 29

change from baseline, improvement

Secondary/protocol endpoint

Change in blood pressure from baseline

Time frame:MAD:Baseline up to Day 50

change from baseline, improvement

Safety / tolerability / PK

11 endpoints

Primary/protocol endpoint

Number of participants with treatment-related adverse events as accessed by CTCAE v6.0

Time frame:SAD: Screening period up to day 29 MAD: Screening period up to day 50

event count, event

Secondary/protocol endpoint

Maximum plasma concentration (Cmax)

Time frame:SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.

concentration, descriptive

Secondary/protocol endpoint

Area under the concentration-time curve from time 0 to the last measurable time point (AUClast)

Time frame:SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.

concentration, descriptive

Secondary/protocol endpoint

Area under the concentration time curve from time 0 to infinity (AUCinf)

Time frame:SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.

concentration, descriptive

Secondary/protocol endpoint

Percent of AUC extrapolated to infinity (AUC_Extrap)

Time frame:SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.

concentration, descriptive

Secondary/protocol endpoint

Time to maximum concentration (Tmax)

Time frame:SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.

time to event, event

Secondary/protocol endpoint

Elimination half-life (t1/2)

Time frame:SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.

concentration, descriptive

Secondary/protocol endpoint

Apparent volume of distribution (Vz/F)

Time frame:SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.

descriptive

Secondary/protocol endpoint

Apparent clearance (CL/F)

Time frame:SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.

concentration, descriptive

Secondary/protocol endpoint

Anti-SYH2069 antibody (ADA)

Time frame:SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.

descriptive

Secondary/protocol endpoint

Corrected QT(QTc) interval

Time frame:SAD: Pre-dose at day 1 to day 8 MAD: Pre-dose at day 1 to day 29

descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Mean change in glucagon from baseline

Time frame:SAD: Baseline up to Day 29 MAD: Baseline up to Day 50

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Body Fat from baseline via Bioelectrical Impedance Analysis (BIA)

Time frame:MAD: Baseline up to Day 29

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Skeletal Muscle from baseline via Bioelectrical Impedance Analysis (BIA)

Time frame:MAD: Baseline up to Day 29

change from baseline, improvement

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.