Overweight or ObesityPhase 2NCT07803991
Efficacy and Safety of SYH2069 Injection in Obese Participants Without Diabetes.
A Phase 2 study testing SYH2069 Injection in people with Overweight or Obesity, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of SYH2069 injection compared with placebo in obese Non-diabetic Participants after 28 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- SYH2069 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Yan Bi, 86-25-83106666, biyan@nju.edu.cn
About this study
Official 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
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
- Being tested
- SYH2069 Injection, SYH2069 Injection Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2069 InjectionDrug
0.6ml , 1.2ml , administered subcutaneously (SC)，Administer the drug according to the clinical trial protocol
SYH2069 Injection PlaceboDrug
0.6ml , 1.2ml , SC，Administer the drug according to the clinical trial protocol
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Active comparator | SYH2069 dose 1 :
SYH2069 Injection: dose level 1 for 28 weeks Receives: Drug: SYH2069 Injection |
| Treatment group B | Experimental | SYH2069 dose 2:
SYH2069 Injection: dose level 2 for 28 weeks Receives: Drug: SYH2069 Injection |
| Treatment group C | Experimental | SYH2069 dose 3:
SYH2069 Injection: dose level 3 for 28 weeks Receives: Drug: SYH2069 Injection |
| Treatment group D | Experimental | SYH2069 dose 4:
SYH2069 Injection: dose level 4 for 28 weeks Receives: Drug: SYH2069 Injection |
| Treatment group E | Experimental | SYH2069 dose 5:
SYH2069 Injection: dose level 5 for 28 weeks Receives: Drug: SYH2069 Injection |
| Treatment group F | Experimental | SYH2069 dose 6:
SYH2069 Injection: dose level 6 for 28 weeks Receives: Drug: SYH2069 Injection |
| Treatment group G | Experimental | SYH2069 dose 7:
SYH2069 Injection: dose level 7 for 28 weeks Receives: Drug: SYH2069 Injection |
| Treatment group H | Experimental | SYH2069 dose 8:
SYH2069 Injection: dose level 8 for 28 weeks Receives: Drug: SYH2069 Injection |
| Treatment group I | Placebo comparator | SYH2069 Injection Placebo:
Placebo arm matching active arm SYH2069 Injection dose level for 28 weeks Receives: Drug: SYH2069 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment
Measured: 28 weeks
Secondary outcomes (19)
Proportion of subjects with a weight loss of ≥5% , 10%, 15% from baseline at 28 weeks of treatment
Measured: Baseline through Week 28
Change from baseline in body Weight
Measured: Week 2, 4, 8, 12, 16, 20, 24 and 28
Changes from baseline in waist circumference
Measured: Baseline through Week 28
Changes from baseline in hip circumference
Measured: Baseline through Week 28
Changes from baseline in waist-to-hip ratio
Measured: Baseline through Week 28
Changes from baseline in Body Mass Index (BMI)
Measured: Baseline through Week 28
Changes from baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline through Week 28
Changes from baseline in fasting plasma glucose (FPG)
Measured: Baseline through Week 28
Changes from baseline in fasting C-peptide
Measured: Baseline through Week 28
Changes from baseline in Homeostatic Model Assessment of Insulin Resistance(HOMA-IRs)
Measured: Baseline through Week 28
Changes from baseline in systolic blood pressure
Measured: Baseline through Week 28
Changes from baseline in diastolic blood pressure
Measured: Baseline through Week 28
Changes from baseline in lipid parameters (TC, LDL-C, HDL-C, non-HDL-C, TG, ApoB)
Measured: Baseline through Week 28
Changes from baseline in high sensitivity C reactive protein (hs-CRP)
Measured: Baseline through Week 28
Changes from baseline in urinary albumin-to-creatinine ratio (UACR)
Measured: Baseline through Week 28
The incidence rate of adverse events (AEs)
Measured: Baseline through Week 31
Plasma concentrations & PK parameters: Peak Time (Tmax)
Measured: Baseline through Week 31
Plasma concentrations & PK parameters: Peak Plasma Concentration (Cmax)
Measured: Baseline through Week 31
Plasma concentrations & PK parameters: Area under the plasma concentration versus time curve(AUC) : AUClast, AUC0-168h, AUC0-336h
Measured: Baseline through Week 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized, double-blind, placebo parallel-controlled Phase II clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803991
- Sponsor's protocol ID
- SYH2069-004
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No