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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight or Obesity
• Intervention / Treatment: Drug: SYH2069 Injection; Drug: SYH2069 Injection Placebo

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group Officer; Phone Number: 86-0311-69085587; Email: ctr-contact@cspc.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
      • Contact: Yan Bi; Phone Number: 86-25-83106666; Email: biyan@nju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment group A; SYH2069 dose 1 : SYH2069 Injection: dose level 1 for 28 weeks	Drug: SYH2069 Injection; 0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol
Experimental: Treatment group B; SYH2069 dose 2: SYH2069 Injection: dose level 2 for 28 weeks	Drug: SYH2069 Injection; 0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol
Experimental: Treatment group C; SYH2069 dose 3: SYH2069 Injection: dose level 3 for 28 weeks	Drug: SYH2069 Injection; 0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol
Experimental: Treatment group D; SYH2069 dose 4: SYH2069 Injection: dose level 4 for 28 weeks	Drug: SYH2069 Injection; 0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol
Experimental: Treatment group E; SYH2069 dose 5: SYH2069 Injection: dose level 5 for 28 weeks	Drug: SYH2069 Injection; 0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol
Experimental: Treatment group F; SYH2069 dose 6: SYH2069 Injection: dose level 6 for 28 weeks	Drug: SYH2069 Injection; 0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol
Experimental: Treatment group G; SYH2069 dose 7: SYH2069 Injection: dose level 7 for 28 weeks	Drug: SYH2069 Injection; 0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol
Experimental: Treatment group H; SYH2069 dose 8: SYH2069 Injection: dose level 8 for 28 weeks	Drug: SYH2069 Injection; 0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol
Placebo Comparator: Treatment group I; SYH2069 Injection Placebo: Placebo arm matching active arm SYH2069 Injection dose level for 28 weeks	Drug: SYH2069 Injection Placebo; 0.6ml , 1.2ml , SC，Administer the drug according to the clinical trial protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment	28 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with a weight loss of ≥5% , 10%, 15% from baseline at 28 weeks of treatment	Baseline through Week 28
Change from baseline in body Weight	Week 2, 4, 8, 12, 16, 20, 24 and 28
Changes from baseline in waist circumference	Baseline through Week 28
Changes from baseline in hip circumference	Baseline through Week 28
Changes from baseline in waist-to-hip ratio	Baseline through Week 28
Changes from baseline in Body Mass Index (BMI)	Baseline through Week 28
Changes from baseline in Hemoglobin A1c (HbA1c)	Baseline through Week 28
Changes from baseline in fasting plasma glucose (FPG)	Baseline through Week 28
Changes from baseline in fasting C-peptide	Baseline through Week 28
Changes from baseline in Homeostatic Model Assessment of Insulin Resistance(HOMA-IRs)	Baseline through Week 28
Changes from baseline in systolic blood pressure	Baseline through Week 28
Changes from baseline in diastolic blood pressure	Baseline through Week 28
Changes from baseline in lipid parameters (TC, LDL-C, HDL-C, non-HDL-C, TG, ApoB)	Baseline through Week 28
Changes from baseline in high sensitivity C reactive protein (hs-CRP)	Baseline through Week 28
Changes from baseline in urinary albumin-to-creatinine ratio (UACR)	Baseline through Week 28
The incidence rate of adverse events (AEs)	Baseline through Week 31
Plasma concentrations & PK parameters: Peak Time (Tmax)	Baseline through Week 31
Plasma concentrations & PK parameters: Peak Plasma Concentration (Cmax)	Baseline through Week 31
Plasma concentrations & PK parameters: Area under the plasma concentration versus time curve(AUC) : AUClast, AUC0-168h, AUC0-336h	Baseline through Week 31

Collaborators and Investigators

• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 25, 2026
• First Submitted That Met QC Criteria: August 31, 2026
• First Posted (Actual): September 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: SYH2069-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No