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

NCT07803991 | Not Yet Recruiting Phase 2

• 1 other identifier: SYH2069-004
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

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

  28 weeks

Secondary Outcomes (19)

• 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

Study Arms (9)

Treatment group A

ACTIVE COMPARATOR

SYH2069 dose 1 : SYH2069 Injection: dose level 1 for 28 weeks

Drug: SYH2069 Injection

Treatment group B

EXPERIMENTAL

SYH2069 dose 2: SYH2069 Injection: dose level 2 for 28 weeks

Drug: SYH2069 Injection

Treatment group C

EXPERIMENTAL

SYH2069 dose 3: SYH2069 Injection: dose level 3 for 28 weeks

Drug: SYH2069 Injection

Treatment group D

EXPERIMENTAL

SYH2069 dose 4: SYH2069 Injection: dose level 4 for 28 weeks

Drug: SYH2069 Injection

Treatment group E

EXPERIMENTAL

SYH2069 dose 5: SYH2069 Injection: dose level 5 for 28 weeks

Drug: SYH2069 Injection

Treatment group F

EXPERIMENTAL

SYH2069 dose 6: SYH2069 Injection: dose level 6 for 28 weeks

Drug: SYH2069 Injection

Treatment group G

EXPERIMENTAL

SYH2069 dose 7: SYH2069 Injection: dose level 7 for 28 weeks

Drug: SYH2069 Injection

Treatment group H

EXPERIMENTAL

SYH2069 dose 8: SYH2069 Injection: dose level 8 for 28 weeks

Drug: SYH2069 Injection

Treatment group I

PLACEBO COMPARATOR

SYH2069 Injection Placebo: Placebo arm matching active arm SYH2069 Injection dose level for 28 weeks

Drug: SYH2069 Injection Placebo

Interventions

SYH2069 Injection DRUG

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

Treatment group A; Treatment group B; Treatment group C; Treatment group D; Treatment group E; Treatment group F; Treatment group G; Treatment group H

SYH2069 Injection Placebo DRUG

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

Treatment group I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Participants with a history of diabetes mellitus or hypoglycemic episodes;
• \. Participants with obesity caused by known single-gene mutations, other medical conditions, or medications, or weight gain not resulting from increased adipose tissue mass;
• \. Use of any medications or products that alter body weight and interfere with weight assessment within 3 months prior to screening;
• \. Prior bariatric surgery or weight-loss interventions, or plan to receive any bariatric surgery or weight-loss intervention during the trial.
• \. 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.
• \. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
• \. Prior history of acute or chronic pancreatitis or pancreatic injury; history of acute gallbladder disease within 1 year prior to screening; .
• \. History of severe cardiovascular or cerebrovascular events within 6 months prior to screening.
• \. 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;
• \. Any treated or untreated malignancy diagnosed from 5 years before screening through randomization (clinically cured basal cell carcinoma or carcinoma in situ are exempted).
• \. Clinically significant hematological diseases, hemolytic or red blood cell disorders, or baseline conditions that interfere with HbA1c measurement at screening or randomization.
• \. Participants with inadequately controlled blood pressure
• \. History of alcohol abuse, substance misuse or illicit drug use prior to screening
• \. Severe trauma, severe or acute infection occurring within 3 months prior to screening or between screening and randomization
• \. Prior clinical trial exposure to study drug within 90 days pre-screening or 5 drug half-lives, whichever is longer.

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trials Information Group Officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, randomized, double-blind, placebo parallel-controlled Phase II clinical study

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-08

Locations

CN (1)