Can a pill tame obesity? new oral drug heads to early human tests
NCT ID NCT07793019
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This early-stage trial tests an investigational oral medicine called IBI3042, which is being developed as a potential treatment for overweight and obesity. The study has two parts: Part A gives a single dose to healthy adults, while Part B gives repeated doses over 13 weeks to adults with overweight or obesity. The main goal is to check the drug's safety and tolerability, and researchers will also measure how the body processes it and explore its effects on body weight and other metabolic measures. Some participants will receive a placebo, and some Part B groups will also receive orforglipron for comparison.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IBI3042, an investigational oral drug for overweight and obesity
- What this could lead to
- If successful, this could lead to a new oral treatment option for overweight and obesity, offering an alternative to injectable therapies.
- What could go wrong
- This is an early Phase 1 trial focused on safety, so it is too soon to know if IBI3042 will be effective or safe for long-term use. Side effects are possible, and the drug may not work as hoped.
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 104 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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Jan 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 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Aged 18 to 55 years, inclusive. * For Part A: BMI ≥20 and \<30 kg/m\^2 and body weight ≥50 kg. * For Part B: BMI ≥24 and ≤40 kg/m\^2, with stable body weight during the 3 months prior to screening. * Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose. * Able and willing to comply with study procedures and voluntarily provide written informed consent. Exclusion Criteria: * Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists. * History of diabetes or abnormal glycemic parameters at screening. * Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng/L at screening. * History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening. * Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening. * Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments. * Clinically significant abnormalities in physical examination or laboratory tests at screening. * History of malignancy within 5 years, except for basal cell or squamous cell skin cancer. * Use of prescription or over-the-counter medications, dietary supplements, or herbal medicines within 2 weeks or 5 half-lives prior to screening, except as permitted by the protocol. * Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable. * Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the 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.
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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Peking University First Hospital
Beijing, Beijing Municipality, 100009, China
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