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Healthy men to test two insulin shots in Early-Stage study

NCT ID NCT07591519

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 2 times

Summary

This early-stage trial will compare two insulin formulations—IBI3035 and insulin icodec (Awiqli)—in 144 healthy Chinese men aged 18 to 45. Researchers will measure how the body absorbs and processes each insulin and how they affect blood sugar levels. The goal is to see if the two formulations are similar enough to be considered interchangeable, not to treat any disease.

What this could mean

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

Active substance
IBI3035 and insulin icodec (Awiqli)

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 144 people

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

Started

May 2026

Expected to finish

Aug 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 45 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 The following inclusion criteria must be met: 1. Healthy male adult subjects aged 18 to 45 years (including 18 and 45 years, based on the date of signing the informed consent form) of Chinese nationality; 2. Body Mass Index (BMI) between 19.0 and 24.0 kg/m2 (including both values) at screening, and weight ≥ 50 kg; 3. Normal glucose tolerance at screening \[3.9 mmol/L \< fasting blood glucose \< 6.1 mmol/L, and 2-hour post-glucose load blood glucose \< 7.8 mmol/L in the oral glucose tolerance test (OGTT)\]; normal insulin secretion function or abnormality without clinical significance as determined by the investigator \[confirmed by the insulin release test (IRT)\]; 4. Glycated hemoglobin ≤ 6.0% at screening; 5. Agree to take effective contraceptive measures during the study period and within 6 months after the last dose and have no plan to donate sperm; 6. Able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete the trial, and voluntarily sign the informed consent form. Exclusion Criteria Subjects who meet any of the following exclusion criteria cannot be included in this study: 1. Known or suspected to be allergic to the investigational drug in this study; 2. Have taken any drugs that affect insulin hypoglycemic effects within 28 days before screening (such as corticosteroids, diuretics, epinephrine, salbutamol, glucagon, thyroid hormones, etc.); 3. Have a history of clinical significance as determined by the investigator at screening or before randomization, including diseases of the endocrine system, blood system, cardiovascular system, respiratory system, digestive system, urinary system, immune system, nervous system, or any other disease that can significantly alter the absorption, metabolism, or elimination of drugs; 4. Have a clear diagnosis of hyperglycemia or hypoglycemia within 3 months before screening; 5. Have an increased risk of thrombosis at screening, including personal or family history of deep vein thrombosis; 6. Have abnormal indicators with clinical significance at screening or before randomization: vital signs, physical examination, laboratory tests, chest X-ray, and 12-lead ECG as determined by the investigator; 7. Have had a severe infection, trauma, or surgery within 4 weeks before screening; 8. Have smoked more than 5 cigarettes per day within 3 months before screening, or have smoked within 48 hours before using the investigational drug or cannot stop using any tobacco products during the trial; 9. Have used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, or health supplements (except for regular vitamin supplements) within 2 weeks before screening; 10. Have donated blood ≥ 400 ml or had any component blood donation within 3 months before screening, or have lost a total of ≥ 400 ml of blood for any reason, or have a history of blood transfusion or use of blood products; 11. Have consumed more than 14 units of alcohol per week within 3 months before screening: 1 unit ≈ 360 ml of beer, or 45 ml of spirits, or 150 ml of wine, and cannot abstain from alcohol within 48 hours before using the investigational drug; 12. Have consumed excessive amounts of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup ≈ 250 ml) daily within 3 months before screening; 13. Have positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or Treponema pallidum antibodies; 14. Have a history of drug abuse or drug use within 3 months before screening, or have positive results for alcohol tests or urine drug screening at screening. 15. Participants who have participated in other clinical trials and used investigational drugs or medical devices within the 3 months prior to screening; 16\. Participants with a weight change greater than 5% within the 3 months prior to screening \[(maximum weight within the 3 months prior to screening - minimum weight within the 3 months prior to screening) / minimum weight within the 3 months prior to screening × 100%, as self-reported by the participant\]; 17. Participants with any food allergies or special dietary requirements that prevent them from adhering to a uniform diet (such as intolerance to standard meal foods, lactose intolerance, etc.); 18. Participants who have experienced acute diseases during the screening period; 19. Participants with a history of fainting at the sight of needles or blood, who cannot tolerate venipuncture blood collection, or who have difficulty with blood collection; 20. Participants for whom the investigator deems there to be any circumstances that make them unsuitable for participation in the trial.

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As listed by the trial registrant

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

How to take part

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  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.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Bishan Hospital of Chongqing

    RECRUITING

    Chongqing, Chongqing Municipality, 402760, China

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