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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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).
Show all 17Show fewer
  • 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.

Clinical Trials Information Group Officer contact

86-0311-69085587

ctr-contact@cspc.cn

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

Other trials in China

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.

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 groups in NCT07803991
Study groupRoleWhat they receive
Treatment group AActive comparatorSYH2069 dose 1 : SYH2069 Injection: dose level 1 for 28 weeks
Receives: Drug: SYH2069 Injection
Treatment group BExperimentalSYH2069 dose 2: SYH2069 Injection: dose level 2 for 28 weeks
Receives: Drug: SYH2069 Injection
Treatment group CExperimentalSYH2069 dose 3: SYH2069 Injection: dose level 3 for 28 weeks
Receives: Drug: SYH2069 Injection
Treatment group DExperimentalSYH2069 dose 4: SYH2069 Injection: dose level 4 for 28 weeks
Receives: Drug: SYH2069 Injection
Treatment group EExperimentalSYH2069 dose 5: SYH2069 Injection: dose level 5 for 28 weeks
Receives: Drug: SYH2069 Injection
Treatment group FExperimentalSYH2069 dose 6: SYH2069 Injection: dose level 6 for 28 weeks
Receives: Drug: SYH2069 Injection
Treatment group GExperimentalSYH2069 dose 7: SYH2069 Injection: dose level 7 for 28 weeks
Receives: Drug: SYH2069 Injection
Treatment group HExperimentalSYH2069 dose 8: SYH2069 Injection: dose level 8 for 28 weeks
Receives: Drug: SYH2069 Injection
Treatment group IPlacebo comparatorSYH2069 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.

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

    Measured: 28 weeks

Secondary outcomes (19)

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

    Measured: Baseline through Week 28

  2. Change from baseline in body Weight

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

  3. Changes from baseline in waist circumference

    Measured: Baseline through Week 28

  4. Changes from baseline in hip circumference

    Measured: Baseline through Week 28

  5. Changes from baseline in waist-to-hip ratio

    Measured: Baseline through Week 28

  6. Changes from baseline in Body Mass Index (BMI)

    Measured: Baseline through Week 28

  7. Changes from baseline in Hemoglobin A1c (HbA1c)

    Measured: Baseline through Week 28

  8. Changes from baseline in fasting plasma glucose (FPG)

    Measured: Baseline through Week 28

  9. Changes from baseline in fasting C-peptide

    Measured: Baseline through Week 28

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

    Measured: Baseline through Week 28

  11. Changes from baseline in systolic blood pressure

    Measured: Baseline through Week 28

  12. Changes from baseline in diastolic blood pressure

    Measured: Baseline through Week 28

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

    Measured: Baseline through Week 28

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

    Measured: Baseline through Week 28

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

    Measured: Baseline through Week 28

  16. The incidence rate of adverse events (AEs)

    Measured: Baseline through Week 31

  17. Plasma concentrations & PK parameters: Peak Time (Tmax)

    Measured: Baseline through Week 31

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

    Measured: Baseline through Week 31

  19. 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.

  1. First posted4 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Information Group Officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment (time frame: 28 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07803991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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