Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

Innovent Biologics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Overweight or Obesity

Treatments: Drug: Placebo; Drug: IBI362

Study type: Interventional

Funder types: Industry

Identifiers

NCT04440345

CIBI362B101

Details and patient eligibility

About

This trial is conducted in China. The aim of this trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of IBI362 in Overweight or Obese Male and Female Subjects.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have stable body weight for the past 12 weeks prior to screening
2. Have a body mass index (BMI) ≥24 kilograms per meter squared (kg/m²) with complication, or BMI≥28 kg/m²,inclusive at screening
3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Exclusion criteria

1. Have a diagnosis of type 2 diabetes
2. Have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening
3. Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or GCG(glucagon)receptor agonists before.
4. Surgical treatment for obesity
5. Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), triglycerides above 500 mg/dL
6. Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
7. Unwilling to comply with smoking and alcohol restrictions during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

IBI362

Experimental group

Description:

Participants received dose 1 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 2 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 3 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 4 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 5 level of IBI362 administered as multiple subcutaneous doses.

Treatment:

Drug: IBI362

placebo

Placebo Comparator group

Description:

Participants received matching placebo dose regiments by subcutaneous injection

Treatment:

Drug: Placebo