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

Innovent Biologics

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo; Drug: Tirzepatide; Drug: IBI362

Study type: Interventional

Funder types: Industry

Identifiers

NCT07000955

CIBI362B104

Details and patient eligibility

About

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

Enrollment: 98 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;

Exclusion criteria

• 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;
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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98 participants in 3 patient groups, including a placebo group

IBI362

Experimental group

Description:

Stage 1: subcutaneous injection, qw; dose ranging from 2.0mg to 15.0mg，44w Stage 2: subcutaneous injection, q2w; 12.0mg or 15.0mg, 12w;

Treatment:

Drug: IBI362

Placebo

Placebo Comparator group

Description:

Stage 1: subcutaneous injection, 0mg, qw, 44w Stage 2: subcutaneous injection, dose ranging from 2.0mg to 6.0mg，qw, 12w

Treatment:

Drug: Placebo

Tirzepatide

Active Comparator group

Description:

Open label: subcutaneous injection, qw, dose ranging from 2.5mg to 15.0mg, 44w

Treatment:

Drug: Tirzepatide