NCT06545162

Brief Summary

This randomized, double-blind, placebo-controlled Phase I clinical study was designed to evaluate the tolerability and safety, PK profile, immunogenicity of CPX101 in a single dose in healthy participants and multiple doses in overweight and obese patients, and to initially explore the efficacy of multiple doses in weight loss. The study was divided into two parts: single administration and dose escalation (SAD) and multiple administration and dose escalation (MAD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

December 4, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

July 31, 2024

Last Update Submit

April 13, 2026

Conditions

Overweight and Obesity

Keywords

GLP-1R

Outcome Measures

Primary Outcomes (4)

  • The safety of CPX101

    All AE/SAEs and other findings from vital signs(temperature, pulse, respiration, blood pressure）, physical examination(general conditions, skin, head and neck, chest, abdomen, back, four limbs, nervous system), lab tests(such as FSH, hematology, urinalysis, liver and kidney functions, electrolytes, fasting plasma glucose, blood lipids, blood amylase and lipase, calcitonin, thyroid function et al) and ECG(heart rate and measures PR, QRS, QT, and QTc intervals) will be collected from the start of screening visit to the end of the study in healthy participants

    Up to 84 days after administration

  • The tolerability of CPX101

    All AE/SAEs and other findings from vital signs(temperature, pulse, respiration, blood pressure）, physical examination(general conditions, skin, head and neck, chest, abdomen, back, four limbs, nervous system), lab tests(such as FSH, hematology, urinalysis, liver and kidney functions, electrolytes, fasting plasma glucose, blood lipids, blood amylase and lipase, calcitonin, thyroid function et al) and ECG(heart rate and measures PR, QRS, QT, and QTc intervals) will be collected from the start of screening visit to the end of the study in healthy participants

    Up to 84 days after administration

  • The safety of CPX101

    All AE/SAEs and other findings from vital signs(temperature, pulse, respiration, blood pressure）, physical examination(general conditions, skin, head and neck, chest, abdomen, back, four limbs, nervous system), lab tests(such as FSH, hematology, urinalysis, liver and kidney functions, electrolytes, fasting plasma glucose, blood lipids, blood amylase and lipase, calcitonin, thyroid function et al) and ECG(heart rate and measures PR, QRS, QT, and QTc intervals) will be collected from the start of screening visit to the end of the study in overweight and obese patients

    Up to 196 days after administration

  • The tolerability of CPX101

    All AE/SAEs and other findings from vital signs(temperature, pulse, respiration, blood pressure）, physical examination(general conditions, skin, head and neck, chest, abdomen, back, four limbs, nervous system), lab tests(such as FSH, hematology, urinalysis, liver and kidney functions, electrolytes, fasting plasma glucose, blood lipids, blood amylase and lipase, calcitonin, thyroid function et al) and ECG(heart rate and measures PR, QRS, QT, and QTc intervals) will be collected from the start of screening visit to the end of the study in overweight and obese patients

    Up to 196 days after administration

Secondary Outcomes (4)

  • Pharmacokinetic (PK) characteristics of CPX101

    Up to 84 days after administration

  • Preliminary efficacy of CPX101

    At week 16 after administration

  • Pharmacokinetic (PK) characteristics of CPX101

    Up to 196 days after administration

  • Immunogenicity of CPX101

    Up to 196 days after administration

Study Arms (7)

SAD Cohort 1

EXPERIMENTAL
Biological: CPX101 or placebo 80mg single dose

SAD Cohort 2

EXPERIMENTAL
Biological: CPX101 or placebo 120mg single dose

SAD Cohort 3

EXPERIMENTAL
Biological: CPX101 or placebo 160mg single dose

MAD Cohort 1

EXPERIMENTAL
Biological: CPX101 or placebo 80mg Q2W

MAD Cohort 2

EXPERIMENTAL
Biological: CPX101 or placebo 120mg Q2W

MAD Cohort 3

EXPERIMENTAL
Biological: CPX101 or placebo 160mg Q2W

MAD cohort 4

EXPERIMENTAL

320mg Q2W

Biological: CPX101 or placebo 320mg Q2W

Interventions

CPX101 or placebo 320mg Q2WBIOLOGICAL

Subcutaneous injection of CPX101 or placebo

MAD cohort 4
CPX101 or placebo 80mg single doseBIOLOGICAL

Subcutaneous injection of CPX101 or placebo

SAD Cohort 1
CPX101 or placebo 120mg single doseBIOLOGICAL

Subcutaneous injection of CPX101 or placebo

SAD Cohort 2
CPX101 or placebo 160mg single doseBIOLOGICAL

Subcutaneous injection of CPX101 or placebo

SAD Cohort 3
CPX101 or placebo 80mg Q2WBIOLOGICAL

Subcutaneous injection of CPX101 or placebo

MAD Cohort 1
CPX101 or placebo 120mg Q2WBIOLOGICAL

Subcutaneous injection of CPX101 or placebo

MAD Cohort 2
CPX101 or placebo 160mg Q2WBIOLOGICAL

Subcutaneous injection of CPX101 or placebo

MAD Cohort 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female participants aged 18 to 65 (inclusive) at the time of signing the informed consent form;
  • When screening, body mass index (BMI)\>20 and\<28 kg/m2;
  • During the entire study period, participants must agree to maintain stable dietary and physical activity habits, and have no plans to change their dietary or exercise habits or lose weight;
  • Participants are able to understand and voluntarily sign a written Informed Consent Form (ICF), and are able to complete the relevant procedures and checks in accordance with the protocol;
  • Female participants must meet the following conditions:
  • No possibility of reproduction;
  • Possible fertility: The serum pregnancy test result was negative during screening, and effective contraceptive measures were agreed to be taken throughout the entire trial period and within 12 weeks after the last dose. Egg donation is not allowed within 12 weeks after the last dose;
  • Male participants whose female partners have the potential to conceive must take effective contraceptive measures throughout the entire trial period and within 12 weeks after the last dose, and are not allowed to donate sperm.
  • Male or female participants aged 18 to 75 (inclusive) at the time of signing the informed consent form;
  • When screening, obese individuals with 28 ≤ BMI\<40kg/m2, or overweight individuals with 24 ≤ BMI\<28kg/m2 and at least one of the following weight related comorbidities;
  • During the first 3 months of screening, the weight remained stable;
  • Willing to maintain a stable diet and exercise habits according to the research protocol throughout the entire study period;
  • Participants are able to understand and voluntarily sign a written informed consent form (ICF), and are able to complete the relevant procedures and checks in accordance with the protocol;
  • Female participants must meet the following conditions:
  • No possibility of reproduction;
  • +2 more criteria

You may not qualify if:

  • When screening, if there is a medical history or clinical evidence showing that participants have obvious accompanying diseases (including but not limited to cardiovascular, respiratory, digestive, urinary, neurological/psychiatric, blood, immune, endocrine and metabolic, infection, etc.);
  • During the screening period, acute diseases with clinical significance (such as gastrointestinal diseases, gallbladder diseases, pancreatitis), infections (such as influenza, upper respiratory tract infections), which are judged by the investigator to be not suitable for participants in the trial;
  • Use any prescription medication (excluding hormonal contraceptives), over-the-counter medication, herbal medicine, or health supplement within the first 30 days of randomization;
  • When screening, the physical examination or laboratory test results meet any of the following criteria:
  • Resting systolic blood pressure (SBP)\>140mmHg or\<90mmHg, and/or diastolic blood pressure (DBP)\>90mmHg or\<60mmHg (allow retesting after 10 minutes);
  • When screening, the heart rate should be greater than 100 beats per minute or less than 50 beats per minute (allowing for retesting after 10 minutes);
  • Hepatic dysfunction;
  • Renal dysfunction;
  • During screening, the QTc of ECG examination abnormal;
  • Positive results in urine drug screening or alcohol breath test during screening;
  • When screening, hepatitis B surface antigen (HBsAg) is positive, or syphilis antibody is positive, or human immunodeficiency virus (HIV) antibody is positive, or hepatitis C virus (HCV) antibody is positive;
  • During screening, hemoglobin levels abnormal;
  • Calcitonin ≥ 20ng/L;
  • Glycated hemoglobin ≥ 6.5%;
  • Thyroid dysfunction;
  • +54 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

Beijing hospital

Beijing, Beijing Municipality, 100000, China

Location

Beijing Luhe hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
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 31, 2024

First Posted

August 9, 2024

Study Start

December 4, 2024

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

CN(3)