A randomized, double blind, placebo controlled phase i study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of IBI3046 in chinese participants with overweight or obesity

NCT ID NCT07809945

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

This study evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3046 in Chinese overweight or obese participants, comprising four phases: single ascending dose (SAD), multiple ascending dose (MAD), IBI3046 administration after mazdutide discontinuation, and IBI3046 in combination with mazdutide

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

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 65 years

Sex

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

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.

Obesity obesity disorder Overweight

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101125, China

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