The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without Diabetes

March 14, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Multi-center, Randomized, Double-blind, Placebo-controlled，Parallel-group Clinical Trial to Assess the Efficacy and Safety of Noiiglutide Injection in Obese Subjects Without Diabetes.

The study is being conducted to assess the efficacy and safety of SHR20004 on body weight in obese subjects without diabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
    • Shanxi
      • TaiYuan, Shanxi, China, 030000
        • Shanxi Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Informed consent obtained prior to any trial-related activities
  2. Body mass index (BMI) between 28 and 40 kg/m2(both inclusive)
  3. Diet and exercise management for at least 3 months before screening and less than 5% change in body weight during the previous 3 months（self-reported）.

Exclusion Criteria:

  1. History of endocrine disease or treatment that may significantly affect body weight prior to screening visit
  2. History of diabetes
  3. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)
  4. History of pancreatitis
  5. Previous surgical treatment of obesity
  6. Screening calcitonin of 20 ng/L or above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group A
Drug: SHR20004
SHR20004：low dose
Drug: SHR20004
SHR20004: medium dose
Drug: SHR20004
SHR20004: high dose
Experimental: Treatment group B
Drug: SHR20004
SHR20004：low dose
Drug: SHR20004
SHR20004: medium dose
Drug: SHR20004
SHR20004: high dose
Experimental: Treatment group C
Drug: SHR20004
SHR20004：low dose
Drug: SHR20004
SHR20004: medium dose
Drug: SHR20004
SHR20004: high dose
Placebo Comparator: Treatment group D
Drug: placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in body weight
Time Frame: Week 0, Week 24
Change from baseline in body weight in kilograms
Week 0, Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative change from baseline in body weight(%)
Time Frame: Week 0, Week 24
Relative change from baseline in body weight(%)
Week 0, Week 24
Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline
Time Frame: Week 0, Week 24
Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline
Week 0, Week 24
Change from baseline in fasting plasma glucose
Time Frame: Week 0, Week 24
Change from baseline in fasting plasma glucose in mmol/L
Week 0, Week 24
Change from baseline in fasting insulin
Time Frame: Week 0, Week 24
Change from baseline in fasting insulin in μU/ml
Week 0, Week 24
Change from baseline in fasting C-peptide
Time Frame: Week 0, Week 24
Change from baseline in fasting C-peptide in ng/ml
Week 0, Week 24
Change from baseline in fasting blood lipids
Time Frame: Week 0, Week 24
Change from baseline in fasting blood lipids including TC\TG\H-DLC\L-DLC in mmol/L
Week 0, Week 24
Change from baseline in glycosylated hemoglobin
Time Frame: Week 0, Week 24
Change from baseline in glycosylated hemoglobin(%)
Week 0, Week 24
Change from baseline in blood pressure
Time Frame: Week 0, Week 24
Change from baseline in blood pressure in mmHg
Week 0, Week 24
Change from baseline in waist circumference
Time Frame: Week 0, Week 24
Change from baseline in waist circumference in cm
Week 0, Week 24
Change from baseline in waist-to-hip ratio
Time Frame: Week 0, Week 24
Change from baseline waist-to-hip ratio（waist and hip will be combined to report waist-to-hip ratio)
Week 0, Week 24
Change from baseline in BMI
Time Frame: Week 0, Week 24
Change from baseline in BMI (weight and height will be combined to report BMI in kg/m^2)
Week 0, Week 24
Change from baseline in plasma glucose of 120 minutes after oral glucose tolerance test （OGTT）
Time Frame: Week 0, Week 24
Change from baseline in plasma glucose of 120 minutes after OGTT in mmol/L
Week 0, Week 24
Change from baseline in insulin of 120 minutes after oral glucose tolerance test （OGTT）
Time Frame: Week 0, Week 24
Change from baseline in insulin of 120 minutes after OGTT in μU/ml
Week 0, Week 24
Change from baseline in C-peptide of 120 minutes after oral glucose tolerance test （OGTT）
Time Frame: Week 0, Week 24
Change from baseline in C-peptide of 120 minutes after OGTT in ng/ml
Week 0, Week 24
Change from baseline in AUC0-2h of plasma glucose during OGTT
Time Frame: Week 0, Week 24
Change from baseline in AUC0-2h of plasma glucose during OGTT in mmol*hr/L
Week 0, Week 24
Change from baseline in AUC0-2h of insulin during OGTT
Time Frame: Week 0, Week 24
Change from baseline in AUC0-2h of insulin during OGTT in μU*hr/ml
Week 0, Week 24
Change from baseline in AUC0-2h of C peptide during OGTT
Time Frame: Week 0, Week 24
Change from baseline in AUC0-2h of C peptide during OGTT in ng*hr/ml
Week 0, Week 24
Percentage of subjects developing anti-drug antibody of SHR20004
Time Frame: Week 0-25
Week 0-25
Percentage of subjects with an Adverse events
Time Frame: Week 0-25
Week 0-25
Percentage of subjects with Injection site reactions
Time Frame: Week 0-25
Week 0-25
12-lead ECG
Time Frame: Week 0-25
12-lead ECG in heart rate（beats）, PR interval（ms）, QT interval(ms), QTC interval(ms), and overall conclusion description
Week 0-25
Concentration of SHR20004 in plasma at steady state
Time Frame: Week 8
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR20004-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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