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Overweight or ObesityPhase 1NCT07736404

A Study of SYH2082 Injection in Healthy Participants

A Phase 1 study testing SYH2082 Injection in people with Overweight or Obesity, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate the safety and tolerability of single dose of SYH2082 Injection in healthy participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Overweight or Obesity
What is being tested?
SYH2082 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteChina
Study dates
13 Apr 2026to 30 Dec 2026
Phase
Phase 1
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Fully understands the content, procedures, and possible adverse reactions of the study, and voluntarily signs the ICF before the study;
  • At screening, age 18-55 years (inclusive, at the time of signing the ICF), male or female;
  • At screening, body weight ≥50 kg for males and ≥45 kg for females; body mass index (BMI) between 19.0 and 35.0 kg/m2 (inclusive);
  • Body weight change ≤5% within 3 months prior to screening (including the screening period);
  • From the time of signing the ICF until 6 months after the last dose, the participant (including their partner) has no plans for childbirth and agrees to use highly effective contraceptive measures;

Who cannot join

  • Known or suspected allergy to glucagon-like peptide-1 (GLP-1) or Glucose dependent insulinotropic polypeptide (GIP) receptor agonists or any component of the investigational product; or has an allergic constitution (allergic to multiple drugs and foods);
  • Abnormal results in vital signs, physical examination, laboratory tests, chest X-ray, ultrasound and ECG that are judged by the investigator to be clinically significant within the screening period. Specifically, the following conditions are not excluded: 1)Systolic blood pressure (SBP) < 160 mmHg, diastolic blood pressure (DBP) < 100 mmHg;2)Fasting TG ≤ 3.42 mmol/L, fasting TC ≤ 7.75 mmol/L(with abnormal HDL-C regardless of LDL-C status); 3)Alanine aminotransferase (ALT) < 2 × ULN, aspartate aminotransferase (AST) < 2 × ULN, gamma-glutamyl transferase (GGT) < 2.5 × ULN, and total bilirubin (TBIL) < 1.5 × ULN.4) Blood uric acid <480 μmol/L and never accompanied by physiological abnormalities (gout, etc.); 5) Ultrasound shows fatty liver and excludes causes
  • Meet any of the following at screening: (1) HbA1c > upper limit of normal, or fasting blood glucose ≤ 3.9 mmol/L or ≥ 6.1 mmol/L; (2) Calcitonin ≥ 50 ng/L; (3) eGFR < 90 mL/min/1.73m 2; (4) TSH exceeds the normal reference range; 4) Patients with prolonged QT/QTc interval at screening (QTcF > 450 ms), or have a history of risk factors for torsades de pointes (such as family history of heart failure/cardiomyopathy or long QT syndrome), or are taking concomitant medications that prolong the QT/QTc interval;
  • Those who are positive for any of hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum antibody;
  • History or presence of major cardiovascular, respiratory, digestive, urinary, hematological, endocrine, immune or nervous system diseases;
  • Subjects with severe trauma or major surgery within 6 months prior to screening, or planned to undergo surgery during the trial;
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  • Patients with thyroid nodules diagnosed as C-TIRADS category 3 or above in the past or during the screening period;
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2, or history of pancreatitis or acute or chronic gallbladder disease;
  • Those with a history of malignant tumors, mental illness, depression, anxiety, or epilepsy;
  • History of clinical gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcer);
  • Previous gastrointestinal surgery leading to malabsorption, or long-term use of drugs that have a direct effect on gastrointestinal motility. e.g., bariatric surgery or procedures (e.g., gastric banding), or use of GLP-1 or GIP receptor agonists or drugs or products that, in the opinion of the investigator, may cause weight change and affect weight assessment within 3 months prior to screening.
  • Those who have symptoms such as dermatitis or skin abnormalities at and around the administration site;
  • Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 2 weeks before screening, or less than 5 half-lives since the last dose of the above-mentioned drugs;
  • Use of drugs that may affect glucose metabolism (e.g., systemic steroids, non-selective beta-blockers, monoamine oxidase inhibitors) within 1 month before screening, or less than 5 half-lives since the last dose of the above-mentioned drugs (whichever is longer);

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose of SYH2082 Injection in Healthy Participants

To evaluate the safety and tolerability of single dose of SYH2082 Injection in healthy participants.

Being tested
SYH2082 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.

  • SYH2082 InjectionDrug

    A subcutaneous injection in the abdomen of the corresponding dose of SYH2082 Injection according to the assigned dose cohort.

  • PlaceboDrug

    A subcutaneous injection in the abdomen of the corresponding dose of Placebo according to the assigned dose cohort.

Study groups in NCT07736404
Study groupRoleWhat they receive
SYH2082 Injection ExperimentalExperimentalSingle-ascending dose
Receives: Drug: SYH2082 Injection
Placebo ComparatorPlacebo comparatorSingle dose
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events as accessed by CTCAE v6.0

    Measured: Screening period up to day 57

Secondary outcomes (25)

  1. Maximum plasma concentration (Cmax)

    Measured: Pre-dose at day 1 to day 57

  2. Area under the concentration-time curve from time 0 to the last measurable time point (AUClast)

    Measured: Pre-dose at day 1 to day 57

  3. Area under the concentration time curve from time 0 to infinity (AUCinf)

    Measured: Pre-dose at day 1 to day 57

  4. Percent of AUC extrapolated to infinity (AUC_Extrap)

    Measured: Pre-dose at day 1 to day 57

  5. Time to maximum concentration (Tmax)

    Measured: Pre-dose at day 1 to day 57

  6. Elimination half-life (t1/2)

    Measured: Pre-dose at day 1 to day 57

  7. Apparent volume of distribution (Vz/F)

    Measured: Pre-dose at day 1 to day 57

  8. Apparent clearance (CL/F)

    Measured: Pre-dose at day 1 to day 57

  9. Anti-SYH2082 antibodies (ADA)

    Measured: Pre-dose at day 1 to day 57

  10. Mean change in plasma glucose from baseline

    Measured: Baseline up to Day 57

  11. Mean change in insulin from baseline

    Measured: Baseline up to Day 57

  12. Mean change in C-peptide from baseline

    Measured: Baseline up to Day 57

  13. Mean change in glucagon from baseline

    Measured: Baseline up to Day 57

  14. Mean change in HbA1c from baseline

    Measured: Baseline up to Day 57

  15. Change in body weight from baseline

    Measured: Baseline up to Day 57

  16. Change in waist circumference from baseline

    Measured: Baseline up to Day 57

  17. Mean change in Total Cholesterol(TC) from baseline

    Measured: Baseline up to Day 57

  18. Mean change in Triglycerides(TG) from baseline

    Measured: Baseline up to Day 57

  19. Mean change in Low-Density Lipoprotein Cholesterol(LDLC) from baseline

    Measured: Baseline up to Day 57

  20. Mean change in High-Density Lipoprotein Cholesterol(HDLC) from baseline

    Measured: Baseline up to Day 57

  21. Change in blood pressure from baseline

    Measured: Baseline up to Day 57

  22. Change in Visceral Fat from baseline via Bioelectrical Impedance Analysis (BIA)

    Measured: Baseline up to Day 57

  23. Change in Body Fat from baseline via Bioelectrical Impedance Analysis (BIA)

    Measured: Baseline up to Day 57

  24. Change in Skeletal Muscle from baseline via Bioelectrical Impedance Analysis (BIA)

    Measured: Baseline up to Day 57

  25. Corrected QT(QTc) interval

    Baseline- and placebo-corrected QTcF (ΔΔQTcF)

    Measured: Pre-dose at day 1 to day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2026
  2. Study start13 Apr 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Interventional
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07736404
Sponsor's protocol ID
SYH2082-001
Status last verified
Jul 2026
First submitted
14 Jul 2026
Last updated
30 Jul 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 1 study testing SYH2082 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as accessed by CTCAE v6.0 (time frame: Screening period up to day 57). 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 NCT07736404.

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 30 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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