ClinicalTrials.gg
Not yet recruitingNCT07803991Updated Sep 4, 2026

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

A Phase 2 interventional study of SYH2069 Injection and SYH2069 Injection Placebo in Overweight or Obesity, sponsored by CSPC Ouyi Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Overweight or Obesity

Browse trials for

03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 360 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd. is the lead sponsor of 30 studies on the registry; 15 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1.Male or female participants, 18-65 years of age at the time of signing ;
  • 2.At screening visit, 28.0 kg/m\^2≤≤ 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

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 to any active ingredient or of the 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 diagnosed from 5 years before screening through randomization (clinically cured basal cell carcinoma or carcinoma in situ are exempted).
  • 11. hematological diseases, hemolytic or red blood cell disorders, or baseline conditions that interfere with 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 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
360 participants (estimated)

Study arms

  • Active comparator
    Treatment group A

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

    Drug: SYH2069 Injection

  • Experimental
    Treatment group B

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

    Drug: SYH2069 Injection

  • Experimental
    Treatment group C

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

    Drug: SYH2069 Injection

  • Experimental
    Treatment group D

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

    Drug: SYH2069 Injection

  • Experimental
    Treatment group E

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

    Drug: SYH2069 Injection

  • Experimental
    Treatment group F

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

    Drug: SYH2069 Injection

  • Experimental
    Treatment group G

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

    Drug: SYH2069 Injection

  • Experimental
    Treatment group H

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

    Drug: SYH2069 Injection

  • Placebo comparator
    Treatment group I

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

    Drug: SYH2069 Injection Placebo

Interventions

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

  • DrugSYH2069 Injection Placebo

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

06

What researchers measure

Primary outcomes

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

    Time frame: 28 weeks

Secondary outcomes

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

    Time frame: Baseline through Week 28

  2. Change from baseline in body Weight

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

  3. Changes from baseline in waist circumference

    Time frame: Baseline through Week 28

  4. Changes from baseline in hip circumference

    Time frame: Baseline through Week 28

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

    Time frame: Baseline through Week 28

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

    Time frame: Baseline through Week 28

  7. Changes from baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline through Week 28

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

    Time frame: Baseline through Week 28

  9. Changes from baseline in fasting C-peptide

    Time frame: Baseline through Week 28

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

    Time frame: Baseline through Week 28

  11. Changes from baseline in systolic blood pressure

    Time frame: Baseline through Week 28

  12. Changes from baseline in diastolic blood pressure

    Time frame: Baseline through Week 28

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

    Time frame: Baseline through Week 28

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

    Time frame: Baseline through Week 28

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

    Time frame: Baseline through Week 28

  16. The incidence rate of adverse events (AEs)

    Time frame: Baseline through Week 31

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

    Time frame: Baseline through Week 31

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

    Time frame: Baseline through Week 31

  19. Plasma concentrations & PK parameters: Area under the plasma concentration versus time curve(AUC) : AUClast, AUC0-168h, AUC0-336h

    Time frame: Baseline through Week 31

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07803991
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Clinical Trials Information Group Officer
Contact
ctr-contact@cspc.cn
86-0311-69085587

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: SYH2069

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