Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mellitus

NCT06532578 | Completed Phase 2

• 1 other identifier: CPX101-Ⅱ-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to evaluate the preliminary efficacy, safety, population PK profile, and immunogenicity of CPX101 in subjects with obesity or overweight with weight related comorbidities but without diabetes mellitus.

Conditions

Overweight and Obesity

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

• Efficacy of CPX101 in body weight loss in Kg

  To evaluate the efficacy of CPX101 in body weight loss by dose levels after 24 weeks of multiple subcutaneous injections in overweight and obese subjects without diabetes mellitus.

  Up to 24 weeks after administration

Secondary Outcomes (5)

• Other efficacy parameters of CPX101(Waist circumference in centimeters)

  Up to 24 weeks after administration

• Other efficacy parameters of CPX101(BMI)

  Up to 24 weeks after administration

• Incidence of AE/SAE

  Up to 36 weeks

• The plasma concentration of CPX101

  Up to 24 weeks after administration

• Immunogenicity of CPX101

  Up to 24 weeks after administration

Other Outcomes (1)

• Efficacy of CPX101 in body weight loss in Kg

  At week 36

Study Arms (5)

Cohort 1

EXPERIMENTAL

Biological: CPX101 or placebo 120mg Q2W

Cohort 2

EXPERIMENTAL

Biological: CPX101 or placebo 160mg Q4W

Cohort 3

EXPERIMENTAL

Biological: CPX101 or placebo 160mg Q2W

Cohort 4

EXPERIMENTAL

Biological: CPX101 or placebo 240mg Q4W; Biological: CPX101 or placebo 360mg Q4W

Cohort 5

EXPERIMENTAL

Biological: CPX101 or placebo 240mg Q2W; Biological: CPX101 or placebo 320mg Q2W

Interventions

CPX101 or placebo 120mg Q2W BIOLOGICAL

Subcutaneous injection of CPX101 or placebo

Cohort 1

CPX101 or placebo 160mg Q4W BIOLOGICAL

Subcutaneous injection of CPX101 or placebo

Cohort 2

CPX101 or placebo 160mg Q2W BIOLOGICAL

Subcutaneous injection of CPX101 or placebo

Cohort 3

CPX101 or placebo 240mg Q4W BIOLOGICAL

Subcutaneous injection of CPX101 or placebo

Cohort 4

CPX101 or placebo 240mg Q2W BIOLOGICAL

Subcutaneous injection of CPX101 or placebo

Cohort 5

CPX101 or placebo 360mg Q4W BIOLOGICAL

CPX101 or placebo 360mg Q4W

Cohort 4

CPX101 or placebo 320mg Q2W BIOLOGICAL

CPX101 or placebo 320mg Q2W

Cohort 5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed informed consent.
• Males or females aged 18-75 years (inclusive) at the time of signing the informed consent form (ICF).
• Body mass index (BMI) ≥ 30 kg/m2, or 27≤BMI\<30 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): pre-diabetes, hypertension, dyslipidaemia, obstructive sleep apnoea, ischemic cardiovascular disease, or concomitant weight-bearing joint pain.
• Body weight is stable during the 3-month period prior to screening, and any weight change is less than 5%.
• In the investigator's opinion, are capable and willing to follow the study procedure of the study, including but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain a study diary, and complete required questionnaires.
• At least one self-reported unsuccessful weight loss attempt per investigator judgement.
• Satisfy the following:
• a) For female subjects: i. Female subjects with childbearing potential: Serum pregnancy test result at screening must be negative, and must agree to use at least one of the effective contraceptive methods (refer to appendix 4) from the time of signing the ICF until 12 weeks after the last dose of study drug. If a female subject decides to use any one of user-dependent contraceptive method (refer to Appendix 4), then a second method of contraceptive barrier is required.
• ii. Female subjects with non-childbearing potential: Postmenopausal for at least 12 months, or documented surgically sterile (e.g. hysterectomy, with or without bilateral salpingectomy and bilateral oophorectomy). Females who have only had tubal ligation or other birth control operations are NOT included.
• b) For male subjects: all male subjects should refrain from sperm donation from the time of signing the ICF until 12 weeks after the last dose of study drug. If engaged in sexual relations with a female of child-bearing potential, subjects must use condoms plus 1 additional highly effective (refer to appendix 4) method of contraception during intercourse from the time of signing the ICF until 12 weeks after the last dose of study drug.

You may not qualify if:

• Subjects are excluded from the trial if any of the following criteria apply:
• Glycaemia-related:
• HbA1c ≥6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus.
• Treatment with glucose-lowering agent(s) within 90 days before screening.
• There are severe hypoglycemic events of unknown cause (needing help from others to recover) from 90 days before screening to randomization, or frequent hypoglycemia such as 3 or more hypoglycemic events (blood glucose ≤ 2.8 mmol/L) or hypoglycemia-related symptoms within 30 days before screening.
• Obesity-related:
• Treatment with GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists, or any other medication for the indication of obesity within 3 months before screening.
• Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device excluding liposuction and/or abdominoplasty, if performed \> 1 year before screening.
• Use of drugs with an impact on body weight within 3 months before screening based on investigator's opinion.
• Presence of any clinically significant endocrine disorders (e.g., uncontrolled hyperthyroidism, or hypothyroidism, acromegaly, Cushing syndrome, etc.), which makes the participant unsuitable for the study, as the discretion of the investigator.
• Mental health:
• Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years before screening.
• A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at screening.
• A lifetime history of a suicidal attempt, or suicidal behavior within 30 days before screening.
• Suicidal ideation corresponding to Category 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening.

Sponsors & Collaborators

• Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Paratus Clinical Research

Chatswood, New South Wales, Australia

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 1, 2024
• Study Start: August 13, 2024
• Primary Completion: December 15, 2025
• Study Completion: April 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

AU (1)