New injection IBI3046 tested for weight management
NCT ID NCT07809945
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing an experimental injectable drug called IBI3046 in Chinese adults who are overweight or obese. The trial checks the drug's safety, how the body processes it, and how it affects body weight. Participants receive IBI3046 alone, in combination with another drug called mazdutide, or a placebo. The study also looks at what happens when people switch from mazdutide to IBI3046.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental injectable drug called IBI3046, tested alone and in combination with mazdutide
- What this could lead to
- If IBI3046 proves safe and tolerable, it could become a new injectable option for weight management, either on its own or combined with mazdutide.
- What could go wrong
- This is a Phase I trial with 128 participants, so its main goal is safety, not proof of weight loss. Many early-stage drugs fail to move forward, and injectable weight-loss drugs can cause side effects like nausea or injection-site reactions.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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.Aged between 18 and 65 years (inclusive) at the time of informed consent, male or female; * 2.At screening, 24 kg/m² ≤ BMI ≤ 40 kg/m²; * 3.Body weight change ≤ 5 % within 3 months prior to screening ; * 4.Female participants of child bearing potential and male participants whose partners are of child bearing potential must agree to use highly effective contraceptive methods during the study and for 6 months after the last study drug administration. For female participants of child bearing potential, the pregnancy test result must be negative at screening. Female participants shall not breast feed. Male / female participants must be willing to refrain from sperm / oocyte donation during the study and for 6 months after the last study drug administration; * 5.Able to understand study procedures and requirements, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form. Exclusion Criteria: * 1\. Secondary overweight or obesity caused by drugs, genetic or other systemic diseases. * 2\. Abnormal glucose metabolism, including diabetes history or clinically significant abnormal glycemic indicators at screening. * 3\. Clinically significant abnormal liver function, hematological parameters, ECG indicators or vital signs at screening. * 4\. Positive screening results for infectious pathogen markers. * 5\. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions at screening. * 6\. History of pancreatitis, severe lipid metabolism disorders, severe hypoglycemia or diabetic ketoacidosis. * 7\. Presence of untreated or clinically significant systemic organ diseases, mental disorders or suicidal risk. * 8\. History of malignant tumors (excluding partial skin cancers) within 5 years. * 9\. Positive screening results for infectious pathogen markers. * 10\. Personal or family history of specific thyroid neoplasms or endocrine disorders, or clinically significant abnormal thyroid function and thyroid lesions at screening. * 11\. History of pancreatitis, severe lipid metabolism disorders, severe hypoglycemia or diabetic ketoacidosis. * 12\. Presence of untreated or clinically significant systemic organ diseases, mental disorders or suicidal risk. * 13\. History of malignant tumors (excluding partial skin cancers) within 5 years.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 101125, China
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