New obesity drug IBI362 shows promise in early trial for chinese patients
NCT ID NCT07000955
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called IBI362 in 98 Chinese adults with moderate to severe obesity (BMI ≥ 32.5). Participants receive weekly injections of IBI362, tirzepatide, or a placebo for several weeks. The main goals are to check safety, side effects, and how the drug behaves in the body, while also measuring weight loss. It is an early-stage trial, so results will help decide if larger studies are warranted.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IBI362 (a drug similar to tirzepatide, given as a weekly injection)
- What this could lead to
- If successful, this could point toward a new weight-loss medication for people with severe obesity, offering an alternative to existing treatments.
- What could go wrong
- This is an early-phase trial with only 98 participants, so results may not apply to everyone. Side effects and safety are still being studied, and the drug may not prove effective or safe in larger trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
98 people
The number who actually took part.
- Started
-
Jun 2025
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. The age at the time of screening is 18 to 55 years old (including both ends), male or female; * 2\. BMI≥32.5 kg/m2 during screening; * 3\. At the time of screening, after simple diet and exercise control for at least 12 weeks, the weight change was less than 5% \[(Maximum weight within 3 months before screening - minimum weight within 3 months before screening)/maximum weight within 3 months before screening ×100%, self-reported by the subjects\] * 4\. Fertile subjects agreed to take the contraceptive measures stipulated in this protocol throughout the study and within 3 months after the last treatment. Female subjects with reproductive capacity must have negative pregnancy test results during screening. Female subjects should not breastfeed throughout the study and within 3 months after the last treatment; * 5\. Voluntarily sign the informed consent form and be willing to strictly abide by the requirements and restrictions in the informed consent form and protocol throughout the research period, including but not limited to: diet, exercise, lifestyle management, planned injection of research drugs, keeping research diaries, and completing relevant questionnaires, etc; Exclusion Criteria: * 1\. The investigator suspected that the subjects might be allergic to the study drug or component or have an allergic constitution; * 2\. Use any of the following drugs or treatments within 3 months before screening including but not limited to GLP-1R, GIPR, GCGR, any drugs, Chinese herbal medicines, health supplements or meal replacements that have an impact on body weight, or participated in other clinical trials; * 3\. There is a history or evidence of any of the following diseases before screening or at the time of screening including but not limited to diabetes, have received or plan to undergo bariatric surgery during the research period in the past, with retinopathy in the past or at the time of screening, secondary diseases or drugs lead to obesity, have a history of depression in the past or have a history of serious mental illness in the past, hypertension that has not been stably controlled at the time of screening after at least 4 weeks of antihypertensive drug treatment, a history of malignant tumors was present during the screening, heart disease, A 2A or 2B history or family history of medullary thyroid carcinoma and multiple endocrine adenomatosis (MEN) , history of acute and chronic pancreatitis, limb deformity or disability, have a history of suicidal tendencies or suicidal behaviors, etc according to the protocol. * 4\. Any of the laboratory examination indicators meets the following standards during screening: serum calcitonin ≥20ng/L during screening, alanine aminotransferase ≥2.0×ULN and/or aspartate aminotransferase ≥2.0×ULN and/or total bilirubin ≥1.5×ULN and/or alkaline phosphatase ≥2.0×ULN, eGFR is less than 60 Ml/min/1.73 m2, abnormal thyroid function including FT3, FT4, or TSH, fasting triglycerides ≥5.64 mmol/L (500 mg/dl), blood amylase or lipase 1.0 x ULN; * 5\. During the screening, the 12-lead electrocardiogram showed a heart rate of \<50 beats per minute or \>90 beats per minute; * 6\. There were clinically significant ECGs abnormalities during the screening; * 7\. History of other risk factors for tachycardia; * 8\. The blood donation volume and/or blood loss volume within 3 months prior to screening is ≥400mL, or bone marrow donation has been performed, or there are anemia-related diseases such as hemoglobinopathy, hemolytic anemia, sickle cell anemia, etc., or hemoglobin.. 110g/ L (male) or 100g/L (females). * 9\. The investigators believe that the subjects have any other factors that may affect the efficacy or safety evaluation of this study and are not suitable to participate in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210003, China
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