Overweight or ObesityPhase 1NCT07736391
A Study of SYH2069 Injection in Healthy Participants
A Phase 1 study testing SYH2069 Injection in people with Overweight or Obesity and Diabetes, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of single and multiple doses of SYH2069 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, Diabetes
- 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
- 104 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 30 Nov 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 understand the content, process and possible adverse reactions of the trial, and voluntarily sign the informed consent form before the trial;
- Male or female, aged 18-55 years (inclusive, based on the time of signing the informed consent form) at screening;
- At screening, male body weight ≥ 50 kg, female body weight ≥ 45 kg, SAD study: BMI between 19 and 28 kg/m2 inclusive), MAD study: BMI between 24 and 35 kg/m 2 inclusive);
- Subjects (including partners) have no plans to have children from the time of signing the informed consent form until 6 months after the last dose, and agree to use highly effective contraceptive measures specified in the protocol.
Who cannot join
- Known or suspected allergies to GLP-1 or GIP receptor agonists or any components of the investigational product, or allergic constitution (allergies to multiple drugs and foods);
- Abnormal results of vital signs, physical examination, laboratory tests, chest X-ray, ultrasound, and electrocardiogram, etc., which are judged by the investigator to be clinically significant and unsuitable for participation in the study. Among them, the following conditions were not excluded in the MAD study: (1) systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg; (2) TG ≤ 3.42 mmol/L, TC ≤ 7.75 mmol/L (regardless of whether LDLC is abnormal), and abnormal HDLC; (3) ALT < 2 times × upper limit of normal, AST < 2 times × upper limit of normal, GGT < 2.5 times × upper limit of normal, total bilirubin < 1.5 times × upper limit of normal; (4) Blood uric acid <480 μmol/L and never accompanied by physiological abnormalities (gout, etc.); (5) Ultrasound shows fatty liver and excludes causes other than metabolism;
- 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;
- 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;
Show all 16Show fewer
- Subjects with severe trauma or major surgery within 6 months prior to screening, or planned to undergo surgery during the trial;
- 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 dosing.
- Body weight change ≥ 5% within 3 months prior to screening (inclusive) (only applicable to MAD study；
- 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;
- Use of drugs that may affect glucose metabolism (e.g., systemic steroids, non-selective beta-blockers, monoamine oxidase inhibitors) within 1 month before screening;
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
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 and Multiple Doses of SYH2069 Injection in Healthy Participants
To evaluate the safety and tolerability of single and multiple doses of SYH2069 Injection in healthy participants.
- Conditions
- Overweight or Obesity, Diabetes
- Being tested
- SYH2069 Injection, Placebo
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2069 InjectionDrug
A subcutaneous injection in the abdomen of the corresponding dose of SYH2069 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 group | Role | What they receive |
|---|---|---|
| SYH2069 Injection Experimental | Experimental | Single-ascending dose and multiple-ascending dose Receives: Drug: SYH2069 Injection |
| Placebo Comparator | Placebo comparator | Single-ascending dose and multiple-ascending dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as accessed by CTCAE v6.0
after single and multiple doses
Measured: SAD: Screening period up to day 29 MAD: Screening period up to day 50
Secondary outcomes (25)
Maximum plasma concentration (Cmax)
after single and multiple doses
Measured: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Area under the concentration-time curve from time 0 to the last measurable time point (AUClast)
after single and multiple doses
Measured: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Area under the concentration time curve from time 0 to infinity (AUCinf)
after single and multiple doses
Measured: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Percent of AUC extrapolated to infinity (AUC_Extrap)
Measured: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Time to maximum concentration (Tmax)
after single and multiple doses
Measured: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Elimination half-life (t1/2)
after single and multiple doses
Measured: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Apparent volume of distribution (Vz/F)
after single and multiple doses
Measured: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Apparent clearance (CL/F)
after single and multiple doses
Measured: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Anti-SYH2069 antibody (ADA)
after single and multiple doses
Measured: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Mean change in plasma glucose from baseline
after single and multiple doses
Measured: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in insulin from baseline
after single and multiple doses
Measured: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in C-peptide from baseline
after single and multiple doses
Measured: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in glucagon from baseline
after single and multiple doses
Measured: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in HbA1c from baseline
after multiple doses
Measured: MAD: Baseline up to Day 50
Change in body weight from baseline
after multiple doses
Measured: MAD: Baseline up to Day 50
Change in waist circumference from baseline
after multiple doses
Measured: MAD: Baseline up to Day 50
Mean change in Total Cholesterol(TC) from baseline
after multiple doses
Measured: MAD: Baseline up to Day 29
Mean change in Triglycerides(TG) from baseline
after multiple doses
Measured: MAD: Baseline up to Day 29
Mean change in Low-Density Lipoprotein Cholesterol(LDLC) from baseline
after multiple doses
Measured: MAD: Baseline up to Day 29
Mean change in High-Density Lipoprotein Cholesterol(HDLC) from baseline
after multiple doses
Measured: MAD: Baseline up to Day 29
Change in blood pressure from baseline
after multiple doses
Measured: MAD:Baseline up to Day 50
Change in Visceral Fat from baseline via Bioelectrical Impedance Analysis (BIA)
after multiple doses
Measured: MAD: Baseline up to Day 29
Change in Body Fat from baseline via Bioelectrical Impedance Analysis (BIA)
after multiple doses
Measured: MAD: Baseline up to Day 29
Change in Skeletal Muscle from baseline via Bioelectrical Impedance Analysis (BIA)
after multiple doses
Measured: MAD: Baseline up to Day 29
Corrected QT(QTc) interval
Baseline- and placebo-corrected QTcF ( ΔΔQTcF )
Measured: SAD: Pre-dose at day 1 to day 8 MAD: Pre-dose at day 1 to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start10 Jan 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Nov 2026 (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.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
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
- NCT07736391
- Sponsor's protocol ID
- SYH2069-001
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of SYH2069 Injection in Healthy Participants
- ClinicalTrials.gov ID
- NCT07736391
- Acronym / sponsor ID
- SYH2069-001
- Conditions
- Overweight or Obesity, Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (actual)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of single and multiple doses of SYH2069 Injection in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYH2069 Injection Experimental | Experimental | Drug: SYH2069 InjectionSingle-ascending dose and multiple-ascending dose |
| Placebo Comparator | Placebo comparator | Drug: PlaceboSingle-ascending dose and multiple-ascending dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fully understand the content, process and possible adverse reactions of the trial, and voluntarily sign the informed consent form before the trial;
- Male or female, aged 18-55 years (inclusive, based on the time of signing the informed consent form) at screening;
- At screening, male body weight ≥ 50 kg, female body weight ≥ 45 kg, SAD study: BMI between 19 and 28 kg/m2 inclusive), MAD study: BMI between 24 and 35 kg/m 2 inclusive);
- Subjects (including partners) have no plans to have children from the time of signing the informed consent form until 6 months after the last dose, and agree to use highly effective contraceptive measures specified in the protocol.
Key exclusion criteria (16 listed)
- Known or suspected allergies to GLP-1 or GIP receptor agonists or any components of the investigational product, or allergic constitution (allergies to multiple drugs and foods);
- Abnormal results of vital signs, physical examination, laboratory tests, chest X-ray, ultrasound, and electrocardiogram, etc., which are judged by the investigator to be clinically significant and unsuitable for participation in the study. Among them, the following conditions were not excluded in the MAD study: (1) systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg; (2) TG ≤ 3.42 mmol/L, TC ≤ 7.75 mmol/L (regardless of whether LDLC is abnormal), and abnormal HDLC; (3) ALT < 2 times × upper limit of normal, AST < 2 times × upper limit of normal, GGT < 2.5 times × upper limit of normal, total bilirubin < 1.5 times × upper limit of normal; (4) Blood uric acid <480 μmol/L and never accompanied by physiological abnormalities (gout, etc.); (5) Ultrasound shows fatty liver and excludes causes other than metabolism;
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYH2069 InjectionA subcutaneous injection in the abdomen of the corresponding dose of SYH2069 Injection according to the assigned dose cohort. | Drug | SYH2069 Injection Experimental |
| PlaceboA subcutaneous injection in the abdomen of the corresponding dose of Placebo according to the assigned dose cohort. | Drug | Placebo Comparator |
Primary outcome
Number of participants with treatment-related adverse events as accessed by CTCAE v6.0
Time frame: SAD: Screening period up to day 29 MAD: Screening period up to day 50
after single and multiple doses
25 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Area under the concentration-time curve from time 0 to the last measurable time point (AUClast)
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Area under the concentration time curve from time 0 to infinity (AUCinf)
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Percent of AUC extrapolated to infinity (AUC_Extrap)
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Time to maximum concentration (Tmax)
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Elimination half-life (t1/2)
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Apparent volume of distribution (Vz/F)
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Apparent clearance (CL/F)
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Anti-SYH2069 antibody (ADA)
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Mean change in plasma glucose from baseline
Time frame: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in insulin from baseline
Time frame: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in C-peptide from baseline
Time frame: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in glucagon from baseline
Time frame: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in HbA1c from baseline
Time frame: MAD: Baseline up to Day 50
Change in body weight from baseline
Time frame: MAD: Baseline up to Day 50
Change in waist circumference from baseline
Time frame: MAD: Baseline up to Day 50
Mean change in Total Cholesterol(TC) from baseline
Time frame: MAD: Baseline up to Day 29
Mean change in Triglycerides(TG) from baseline
Time frame: MAD: Baseline up to Day 29
Mean change in Low-Density Lipoprotein Cholesterol(LDLC) from baseline
Time frame: MAD: Baseline up to Day 29
Mean change in High-Density Lipoprotein Cholesterol(HDLC) from baseline
Time frame: MAD: Baseline up to Day 29
Change in blood pressure from baseline
Time frame: MAD:Baseline up to Day 50
Change in Visceral Fat from baseline via Bioelectrical Impedance Analysis (BIA)
Time frame: MAD: Baseline up to Day 29
Change in Body Fat from baseline via Bioelectrical Impedance Analysis (BIA)
Time frame: MAD: Baseline up to Day 29
Change in Skeletal Muscle from baseline via Bioelectrical Impedance Analysis (BIA)
Time frame: MAD: Baseline up to Day 29
Corrected QT(QTc) interval
Time frame: SAD: Pre-dose at day 1 to day 8 MAD: Pre-dose at day 1 to day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYH2069 Injection in people with Overweight or Obesity and Diabetes, 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 16 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: SAD: Screening period up to day 29 MAD: Screening period up to day 50). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.