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New weekly shot challenges semaglutide for diabetes and weight loss

NCT ID NCT06184568

Disease control Sponsor: Innovent Biologics (Suzhou) Co. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 study tested a new drug called IBI362 (mazdutide) against the well-known semaglutide in 349 Chinese adults with early type 2 diabetes and obesity. Participants received weekly injections for 32 weeks, with some continuing for an extra 24 weeks. The main goal was to see how many people achieved both good blood sugar control (HbA1c below 7%) and significant weight loss (at least 10%).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IBI362 (mazdutide) and semaglutide
What this could lead to
If IBI362 works better than semaglutide, it could offer a new once-weekly injection option for people with early type 2 diabetes and obesity to better control blood sugar and lose weight.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The study only included Chinese participants, so findings may not apply to other populations. Side effects from these drugs can include nausea, vomiting, and diarrhea.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

349 people

The number who actually took part.

Started

Feb 2024

Finished

Feb 2026

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 years and older

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: * Male or female, age 18 years or older at the time of signing informed consent * T2D was diagnosed according to WHO standards in 1999(≤5 years) * The blood glucose was not well controlled after diet and exercise with/without sable metformin(≥1500mg/day，no more than 2550mg/day) within 3 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤9.5% during screening * Have a BMI ≥28 kg/m2 Exclusion Criteria: * Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs * A self-reported change in body weight above 5% within 3 months before screening * Oral hypoglycemic drugs other metformin have been used within 2 months before screening. * Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes) * There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery) * Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study * Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period * The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Type 2 diabetes

Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100010, China

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