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ObesityPhase 1/2NCT07000955

Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity

A Phase 1/2 study testing Tirzepatide and IBI362 in people with Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a multicenter, randomized, partially double-blind (double-blind in both the IBI362 group and the placebo group, with the tirbopeptide group open), placebo and active drug controlled design study Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Obesity
What is being tested?
Tirzepatide and IBI362
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
1 siteChina
Study dates
17 Jun 2025to 14 May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 1. The age at the time of screening is 18 to 55 years old (including both ends), male or female;
  • 2. BMI≥32.5 kg/m2 during screening;
  • 3. At the time of screening, after simple diet and exercise control for at least 12 weeks, the weight change was less than 5% [(Maximum weight within 3 months before screening - minimum weight within 3 months before screening)/maximum weight within 3 months before screening ×100%, self-reported by the subjects]
  • 4. Fertile subjects agreed to take the contraceptive measures stipulated in this protocol throughout the study and within 3 months after the last treatment. Female subjects with reproductive capacity must have negative pregnancy test results during screening. Female subjects should not breastfeed throughout the study and within 3 months after the last treatment;
  • 5. Voluntarily sign the informed consent form and be willing to strictly abide by the requirements and restrictions in the informed consent form and protocol throughout the research period, including but not limited to: diet, exercise, lifestyle management, planned injection of research drugs, keeping research diaries, and completing relevant questionnaires, etc;

Who cannot join

  • 1. The investigator suspected that the subjects might be allergic to the study drug or component or have an allergic constitution;
  • 2. Use any of the following drugs or treatments within 3 months before screening including but not limited to GLP-1R, GIPR, GCGR, any drugs, Chinese herbal medicines, health supplements or meal replacements that have an impact on body weight, or participated in other clinical trials;
  • 3. There is a history or evidence of any of the following diseases before screening or at the time of screening including but not limited to diabetes, have received or plan to undergo bariatric surgery during the research period in the past, with retinopathy in the past or at the time of screening, secondary diseases or drugs lead to obesity, have a history of depression in the past or have a history of serious mental illness in the past, hypertension that has not been stably controlled at the time of screening after at least 4 weeks of antihypertensive drug treatment, a history of malignant tumors was present during the screening, heart disease, A 2A or 2B history or family history of medullary thyroid carcinoma and multiple endocrine adenomatosis (MEN) , history of acute and chronic pancreatitis, limb deformity or disability, have a history of suicidal tendencies or suicidal behaviors, etc according to the protocol.
  • 4. Any of the laboratory examination indicators meets the following standards during screening: serum calcitonin ≥20ng/L during screening, alanine aminotransferase ≥2.0×ULN and/or aspartate aminotransferase ≥2.0×ULN and/or total bilirubin ≥1.5×ULN and/or alkaline phosphatase ≥2.0×ULN, eGFR is less than 60 Ml/min/1.73 m2, abnormal thyroid function including FT3, FT4, or TSH, fasting triglycerides ≥5.64 mmol/L (500 mg/dl), blood amylase or lipase 1.0 x ULN;
  • 5. During the screening, the 12-lead electrocardiogram showed a heart rate of <50 beats per minute or >90 beats per minute;
  • 6. There were clinically significant ECGs abnormalities during the screening;
Show all 9Show fewer
  • 7. History of other risk factors for tachycardia;
  • 8. The blood donation volume and/or blood loss volume within 3 months prior to screening is ≥400mL, or bone marrow donation has been performed, or there are anemia-related diseases such as hemoglobinopathy, hemolytic anemia, sickle cell anemia, etc., or hemoglobin.. 110g/ L (male) or 100g/L (females).
  • 9. The investigators believe that the subjects have any other factors that may affect the efficacy or safety evaluation of this study and are not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210003

Other trials in China

About this study

Official title: Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg Administered Multiple Times in Chinese Patients With Moderate to Severe Obesity

This study is a multicenter, randomized, partially double-blind (double-blind in both the IBI362 group and the placebo group, with the tirbopeptide group open), placebo and active drug controlled design study

Conditions
Obesity
Being tested
Tirzepatide, Placebo, IBI362
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Tirzepatide administered subcutaneously (SC) once a week.

  • PlaceboDrug

    Placebo administered subcutaneously (SC) once a week.

  • IBI362Drug

    IBI362 administered subcutaneously (SC) once a week.

Study groups in NCT07000955
Study groupRoleWhat they receive
IBI362ExperimentalStage 1: subcutaneous injection, qw; dose ranging from 2.0mg to 15.0mg，44w Stage 2: subcutaneous injection, q2w; 12.0mg or 15.0mg, 12w;
Receives: Drug: IBI362
PlaceboPlacebo comparatorStage 1: subcutaneous injection, 0mg, qw, 44w Stage 2: subcutaneous injection, dose ranging from 2.0mg to 6.0mg，qw, 12w
Receives: Drug: Placebo
TirzepatideActive comparatorOpen label: subcutaneous injection, qw, dose ranging from 2.5mg to 15.0mg, 44w
Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Incidence of adverse events and serious adverse events during the treatment period

    Measured: week 44

  2. The suicidal ideation and behavior of subjects evaluated by Columbia-Suicide Severity Rating Scale (C-SSRS)

    Measured: week 44

  3. The incidence rates of Adverse Event of Special Interest

    Measured: week 44

  4. The value of systolic and diastolic pressures

    Measured: week 44

  5. The RR interval, PR interval, heart rate, QT interval, Fridericia-corrected QT interval, and any abnormal reporting results of 12-lead electrocardiogram

    Measured: week 44

  6. Any adverse event evaluated by laboratory examinations

    Including amylase, lipase, alanine aminotransferase [ALT], aspartate aminotransferase [AST], calcitonin, urinary albumin-to-creatinine ratio [UACR], creatine kinase [CK], lactate dehydrogenase [LDH], etc

    Measured: week 44

  7. The value of pulse rate

    Measured: week 44

Secondary outcomes (15)

  1. Evaluate the pharmacokinetic (PK) characteristics of IBI362

    Maximum Plasma Concentration Area under the concentration-time curve

    Measured: week 44

  2. The change in body weight from baseline

    Measured: week 44

  3. Immunogenicity

    The incidence of serum anti-IBI362 antibody (ADA) and neutralizing antibody (Nab)

    Measured: week 44

  4. The change in waist circumference from baseline

    Measured: week 44

  5. Changes and percentage changes of abdominal visceral fat (VAT) content, abdominal subcutaneous fat (SAT) content, and abdominal total fat (TAAT) content relative to the baseline

    Measured: week 44

  6. Changes and percentage changes of liver fat content compared with the baseline

    Measured: week 44

  7. The changes in insulin resistance index (HOMA2-IR) and islet β-cell function index (HOMA2-B) from baseline calculated by the concentration of fasting blood glucose and the concentration of fasting insulin

    Measured: week 44

  8. The change in body-mass index from baseline

    Measured: week 44

  9. The change in neck circumference from baseline

    Measured: week 44

  10. The change in hip circumference from baseline

    Measured: week 44

  11. The change in waist circumference/hip circumference ratio from baseline

    Measured: week 44

  12. Changes in hemoglobin A1c (HbA1c%) , from baseline

    Measured: week 44

  13. Changes in fasting blood glucose , from baseline

    Measured: week 44

  14. Changes in Fasting insulin, from baseline

    Measured: week 44

  15. Changes in Fasting C-peptide, from baseline

    Measured: week 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start17 Jun 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion14 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07000955
Sponsor's protocol ID
CIBI362B104
Status last verified
Dec 2025
First submitted
8 May 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tirzepatide and IBI362 in people with Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Incidence of adverse events and serious adverse events during the treatment period (time frame: week 44). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07000955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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