Clinical Trials of IBI3040 in Healthy Participants and Overweight or Obese Participants

NCT07765160 | Not Yet Recruiting Phase 1

• 1 other identifier: CIBI3040A101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical trials of IBI3040 with single-dose administration in healthy participants and multiple-dose administration in overweight or obese participants.

Conditions

Healthy Participants; Overweight or Obese Participants

Outcome Measures

Primary Outcomes (12)

• SAD: The incidence rate of adverse events (AE)

  through study completion, an average of 60 days

• SAD: The incidence rate of serious adverse events (SAE)

  through study completion, an average of 60 days

• SAD: Number of subjects with clinically significant changes in physical examination results

  through study completion, an average of 60 days

• SAD: Number of subjects with clinically significant changes in vital signs

  Vital signs including body temperature, pulse, respiratory rate and blood pressure

  through study completion, an average of 60 days

• SAD: Number of participants with abnormal laboratory tests results

  laboratory tests including Blood routine、Blood Biochemistry (including blood lipids)、Coagulation routine、Urine routine、blood amylase、blood lipase、Pregnancy test、Calcitonin and Glycated hemoglobin (HbA1c)

  through study completion, an average of 60 days

• SAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram

  through study completion, an average of 60 days

• MAD: The incidence rate of adverse events (AE)

  through study completion, an average of 20 weeks

• MAD: The incidence rate of serious adverse events (SAE)

  through study completion, an average of 20 weeks

• MAD: Number of subjects with clinically significant changes in physical examination results

  through study completion, an average of 20 weeks

• MAD: Number of subjects with clinically significant changes in vital signs

  Vital signs including body temperature, pulse, respiratory rate and blood pressure

  through study completion, an average of 20 weeks

• MAD: Number of participants with abnormal laboratory tests results

  laboratory tests including Blood routine、Blood Biochemistry (including blood lipids)、Coagulation routine、Urine routine、blood amylase、blood lipase、Pregnancy test、Calcitonin and Glycated hemoglobin (HbA1c)

  through study completion, an average of 20 weeks

• MAD: Number of subjects with clinically significant changes in twelve-lead electrocardiogram

  through study completion, an average of 20 weeks

Secondary Outcomes (17)

• SAD: area under the curve (AUC)

  through study completion, an average of 60 days

• SAD: maximum concentration (Cmax)

  through study completion, an average of 60 days

• SAD: time to maximum concentration (Tmax)

  through study completion, an average of 60 days

• SAD: clearance (CL/F)

  through study completion, an average of 60 days

• SAD: apparent volume of distribution (V/F)

  through study completion, an average of 60 days

Study Arms (3)

IBI3040

EXPERIMENTAL

IBI3040, specification 0.6 ml:2.4 mg, injection, subcutaneous injection in the abdomen

Drug: SAD: subcutaneous injection in the abdomen; Drug: MAD: subcutaneous injection in the abdomen

IBI362

ACTIVE COMPARATOR

IBI362, specifications: 0.5 ml:2 mg, 0.5 ml:4 mg and 0.5 ml:6 mg, injection, subcutaneous injection in the abdomen

Drug: MAD: subcutaneous injection in the abdomen

IBI3040 Placebo

PLACEBO COMPARATOR

IBI3040 Placebo (without active ingredients), specification 0.6ml, injection, subcutaneous injection in the abdomen

Drug: SAD: subcutaneous injection in the abdomen; Drug: MAD: subcutaneous injection in the abdomen

Interventions

SAD: subcutaneous injection in the abdomen DRUG

SAD: Single subcutaneous administration, with a safe follow-up period of 60 days

IBI3040; IBI3040 Placebo

MAD: subcutaneous injection in the abdomen DRUG

MAD: Multiple administration, subcutaneous injection

IBI3040; IBI3040 Placebo; IBI362

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age at the time of informed consent should be between 18 and 65 years old (including both values), and there is no gender restriction.
• Female participants who are fertile and male participants whose partners are fertile must agree to use the contraceptive methods specified in the protocol during the study period and within 90 days after the last administration. The pregnancy test results of female participants with fertility before randomization must be negative. Female participants should not breastfeed. Male/female participants must be willing to avoid donating sperm/eggs during the study period and within 90 days after the last administration.
• \. Be able to understand the procedures and methods of this research, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.
• \. Participants who were determined by the researchers to be normal or abnormal based on the results of various examinations such as medical history, vital signs, physical examination, 12-lead electrocardiogram, laboratory tests, infectious disease screening, chest X-ray, and abdominal color Doppler ultrasound, but were determined by the researchers to have no clinical significance.
• \. During screening, 20 kg/m ² ≤BMI \<28 kg/m ²;
• \. When screening, the standard weight should be ≥50 kg
• \. During screening, 24 kg/m2 ≤BMI ≤40 kg/m2;
• \. The standard weight change within 3 months prior to screening should be no more than 5kg (reported by the participants themselves).

You may not qualify if:

• Participants may be allergic to any component of the investigational drug, GLP-1 or Amylin receptor agonists (see Appendix 3 for details), or have used GLP-1 or Amylin receptor agonists within 3 months prior to screening;
• \. A history of diabetes, or a glycated hemoglobin level of ≥6.5% during the screening period, or a fasting blood glucose level of ≥7.0 mmol/L;
• \. Previous history of thyroid C-cell carcinoma, multiple endocrine adenomatosis (MEN) 2A or 2B, or related family history, or calcitonin ≥20 ng/L at screening;
• \. A history of acute or chronic pancreatitis in the past, or amylase or lipase \>1.5× upper limit of the normal range (ULN) at the time of screening;
• \. Alanine aminotransferase \>1.5×ULN during the screening period; Or aspartate aminotransferase \>1.5×ULN; Or total bilirubin \>1.5×ULN;
• \. During the screening period, the hepatitis B surface antigen is positive, or the hepatitis C antibody is positive, or the syphilis helix specific antibody is positive, or the HIV antibody is positive;
• \. Abnormal 12-lead electrocardiogram (ECG) during the screening period and judged by the researcher as having clinical significance, or ECG QTcF \>450 ms, or heart rate \<60 beats per minute or \>100 beats per minute;
• \. Having a history of suicidal behavior, or being considered to have a significant suicide risk at present, or having a PHQ (Depression Screening Scale) score of ≥15 at the time of screening, or being classified as category 4 or 5 on the C-SSRS (Columbia Suicide Severity Scale) at the time of screening, or choosing "yes" in suicidal behavior or suicidal ideation;
• \. Use of prescription and over-the-counter drugs within 2 weeks before screening or within 5 half-lives (excluding topical eye/nasal drops and creams without systemic exposure risk);
• \. Have participated in any clinical trials of drugs (or within five half-lives) or medical devices within three months prior to screening, or plan to participate in clinical trials of other drugs or medical devices during the trial period;
• \. Those who consumed an average of more than 2 units of alcohol per day in the three months prior to screening (1 unit of alcohol ≈360 mL of beer with an alcohol content of 5% or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine with an alcohol content of 12%), or those who were unable to quit drinking during the trial period, or those with a positive breath test for alcohol;
• \. Smoking more than 5 cigarettes per day within the 3 months prior to screening;
• \. Those who have a history of drug abuse within the five years prior to screening, or have used drugs within the three months prior to screening, or have a positive urine drug screening result;
• \. Blood donation and/or blood loss within 3 months prior to screening ≥450 mL, or having undergone bone marrow donation, blood transfusion or severe blood loss, or having hemoglobinopathy, hemolytic anemia, sickle cell anemia, or hemoglobin \<120 g/L (for men) or \<110 g/L (for women);
• \. Inability to tolerate venipuncture for blood collection or fainting at the sight of needles and blood;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 201107, China

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shanyu Xu

CONTACT

+86-0512-69566088; shanyu.xu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part A and Part B cohorts 2-6 are randomized, double-blind trials (participants and investigators). From the start of randomization until the database is locked, blinded participants include participants, investigators (excluding non-blinded investigators from the SRC), and all participants who received the medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): November 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

CN (1)