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ObesityPhase 2NCT04799327

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

A Phase 2 study testing SHR20004 in people with Obesity, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
SHR20004
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
254 participants
Where
2 sitesChina
Study dates
29 Mar 2021to 15 May 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent obtained prior to any trial-related activities
  • Body mass index (BMI) between 28 and 40 kg/m2(both inclusive)
  • 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）.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030000

Other trials in China

About this study

Official title: 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.

Conditions
Obesity
Being tested
SHR20004, placebo
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR20004Drug

    SHR20004：low dose

  • SHR20004Drug

    SHR20004: medium dose

  • SHR20004Drug

    SHR20004: high dose

  • placeboDrug

    Placebo

Study groups in NCT04799327
Study groupRoleWhat they receive
Treatment group AExperimentalNot described
Receives: Drug: SHR20004
Treatment group BExperimentalNot described
Receives: Drug: SHR20004
Treatment group CExperimentalNot described
Receives: Drug: SHR20004
Treatment group DPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in body weight

    Change from baseline in body weight in kilograms

    Measured: Week 0, Week 24

Secondary outcomes (22)

  1. Relative change from baseline in body weight(%)

    Relative change from baseline in body weight(%)

    Measured: Week 0, Week 24

  2. Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline

    Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline

    Measured: Week 0, Week 24

  3. Change from baseline in fasting plasma glucose

    Change from baseline in fasting plasma glucose in mmol/L

    Measured: Week 0, Week 24

  4. Change from baseline in fasting insulin

    Change from baseline in fasting insulin in μU/ml

    Measured: Week 0, Week 24

  5. Change from baseline in fasting C-peptide

    Change from baseline in fasting C-peptide in ng/ml

    Measured: Week 0, Week 24

  6. Change from baseline in fasting blood lipids

    Change from baseline in fasting blood lipids including TC\TG\H-DLC\L-DLC in mmol/L

    Measured: Week 0, Week 24

  7. Change from baseline in glycosylated hemoglobin

    Change from baseline in glycosylated hemoglobin(%)

    Measured: Week 0, Week 24

  8. Change from baseline in blood pressure

    Change from baseline in blood pressure in mmHg

    Measured: Week 0, Week 24

  9. Change from baseline in waist circumference

    Change from baseline in waist circumference in cm

    Measured: Week 0, Week 24

  10. Change from baseline in waist-to-hip ratio

    Change from baseline waist-to-hip ratio（waist and hip will be combined to report waist-to-hip ratio)

    Measured: Week 0, Week 24

  11. Change from baseline in BMI

    Change from baseline in BMI (weight and height will be combined to report BMI in kg/m^2)

    Measured: Week 0, Week 24

  12. Change from baseline in plasma glucose of 120 minutes after oral glucose tolerance test （OGTT）

    Change from baseline in plasma glucose of 120 minutes after OGTT in mmol/L

    Measured: Week 0, Week 24

  13. Change from baseline in insulin of 120 minutes after oral glucose tolerance test （OGTT）

    Change from baseline in insulin of 120 minutes after OGTT in μU/ml

    Measured: Week 0, Week 24

  14. Change from baseline in C-peptide of 120 minutes after oral glucose tolerance test （OGTT）

    Change from baseline in C-peptide of 120 minutes after OGTT in ng/ml

    Measured: Week 0, Week 24

  15. Change from baseline in AUC0-2h of plasma glucose during OGTT

    Change from baseline in AUC0-2h of plasma glucose during OGTT in mmol*hr/L

    Measured: Week 0, Week 24

  16. Change from baseline in AUC0-2h of insulin during OGTT

    Change from baseline in AUC0-2h of insulin during OGTT in μU*hr/ml

    Measured: Week 0, Week 24

  17. Change from baseline in AUC0-2h of C peptide during OGTT

    Change from baseline in AUC0-2h of C peptide during OGTT in ng*hr/ml

    Measured: Week 0, Week 24

  18. Percentage of subjects developing anti-drug antibody of SHR20004

    Measured: Week 0-25

  19. Percentage of subjects with an Adverse events

    Measured: Week 0-25

  20. Percentage of subjects with Injection site reactions

    Measured: Week 0-25

  21. 12-lead ECG

    12-lead ECG in heart rate（beats）, PR interval（ms）, QT interval(ms), QTC interval(ms), and overall conclusion description

    Measured: Week 0-25

  22. Concentration of SHR20004 in plasma at steady state

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start29 Mar 2021
  3. Primary completion15 May 2022 (estimated)
  4. Study completion15 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assign to SHR20004 or placebo
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04799327
Sponsor's protocol ID
SHR20004-202
Status last verified
Mar 2021
First submitted
4 Mar 2021
Last updated
15 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR20004 in people with Obesity, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in body weight (time frame: Week 0, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04799327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.

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