ObesityPhase 1NCT07280936
A Study of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple Doses
A Phase 1 study testing SHR-2906 Injection in people with Obesity and Overweight, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial. This study consists of two parts: the single-dose escalation study (SAD) in healthy subjects and the multiple-dose escalation study (MAD) in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- SHR-2906 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2026to Dec 2026
- Phase
- Phase 1
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
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
- Males or females aged 18-55 years (inclusive);
- Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG);
- At screening, 19.0 ≤ BMI ≤ 23.9 kg/m2 (inclusive) for Part I or 28.0 ≤ BMI ≤ 35.0 kg/m2 (inclusive) for Part II.
Who cannot join
- During screening, electrocardiogram (ECG) indicated that QTcF>450 ms in males and QTcF> 470 ms in females, as well as other abnormal ECG and vital signs that were judged by the researchers to have clinical significance;
- There are endocrine diseases or medical histories that may significantly affect body weight during screening (such as Cushing's syndrome, diabetes, hypothyroidism or hyperthyroidism, etc.);
- There is a history or family history of medullary thyroid carcinoma, multiple endocrine adenomatosis type 2, or a history of pancreatitis or symptomatic gallbladder disease;
- Other clinical findings within 12 months prior to screening that show clinical significance in the following diseases (including but not limited to gastrointestinal, kidney, liver, nervous, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases);
- Use of prescription drugs (excluding topical eye/nasal drops and creams without systemic exposure risk), over-the-counter drugs, food supplements, vitamins and Chinese herbal medicines (excluding conventional vitamins) within two weeks prior to screening;
- Having undergone gastrointestinal surgery that may cause malabsorption before screening, or having taken drugs that directly affect gastrointestinal peristalsis for a long time. For example: having undergone bariatric surgery or procedures (such as gastric banding), or having used weight-reducing drugs (including but not limited to orlistat) within 3 months before administration, or having a weight change of more than 10% within 3 months before administration;
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- Those who have a history of drug abuse in the past five years or have used drugs in the three months prior to the trial; Or the urine drug screening is positive;
- Blood donation of ≥200 mL within one month prior to screening; Or those who have donated ≥400 mL of blood or lost ≥400 mL of blood within 3 months prior to screening due to trauma or major surgical operations;
- Inability to tolerate venipuncture for blood collection or fainting at the sight of needles and blood;
- There are special dietary requirements and they cannot follow the uniform diet;
- Subjects who the researchers consider to have other factors that make them unsuitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple Doses
This study is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial. This study consists of two parts: the single-dose escalation study (SAD) in healthy subjects and the multiple-dose escalation study (MAD) in obese patients.
- Conditions
- Obesity, Overweight
- Being tested
- SHR-2906 Injection, SHR-2906 Injection Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2906 InjectionDrug
SHR-2906 injection, in different doses.
SHR-2906 Injection PlaceboDrug
SHR-2906 injection placebo.
| Study group | Role | What they receive |
|---|---|---|
| SHR-2906 Injection Group | Experimental | Not described Receives: Drug: SHR-2906 Injection |
| SHR-2906 Injection Placebo Group | Placebo comparator | Not described Receives: Drug: SHR-2906 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs).
Measured: Part1: 57 days; Part2: 113 days.
Incidence of serious adverse events (SAEs).
Measured: Part1: 57 days; Part2: 113 days.
Secondary outcomes (8)
Maximum concentration (Cmax).
Measured: Part1: 57 days; Part2: 113 days.
Time of maximum concentration (Tmax).
Measured: Part1: 57 days; Part2: 113 days.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last).
Measured: Part1: 57 days; Part2: 113 days.
Area under the concentration-time curve from time zero to infinity (AUC0-inf).
Measured: Part1: 57 days; Part2: 113 days.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau).
Measured: Part1: 57 days; Part2: 113 days.
Elimination half-life (t1/2).
Measured: Part1: 57 days; Part2: 113 days.
Apparent clearance (CL/F).
Measured: Part1: 57 days; Part2: 113 days.
Apparent volume of distribution (Vz/F).
Measured: Part1: 57 days; Part2: 113 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start5 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280936
- Sponsor's protocol ID
- SHR-2906-101
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided