Overweight or ObesityPhase 1/2NCT04440345

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

A Phase 1/2 study testing IBI362 in people with Overweight or Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Overweight or Obesity
What is being tested?: IBI362
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteChina
Study dates: 16 Jun 2020to 6 Aug 2021
Phase: Phase 1/2
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Have a diagnosis of type 2 diabetes
Have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening
Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or GCG(glucagon)receptor agonists before.
Surgical treatment for obesity
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
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
Unwilling to comply with smoking and alcohol restrictions during the study

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University people's hospital
Beijing

Other trials in China

About this study

Official title: Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obese Subjects

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.

Conditions: Overweight or Obesity
Being tested: IBI362, Placebo
Medical subject headings: Overweight, Obesity

What participants receive

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

IBI362Drug
Administered by subcutaneous injection
PlaceboDrug
Administered by subcutaneous injection

Study groups in NCT04440345
Study group	Role	What they receive
IBI362	Experimental	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. Receives: Drug: IBI362
placebo	Placebo comparator	Participants received matching placebo dose regiments by subcutaneous injection Receives: Drug: Placebo

What is being measured

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

Number of treatment adverse events
The relationship of each adverse event to the investigational product was assessed by the investigator.
Measured: From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)

Secondary outcomes (8)

Number of Participants With Anti-IBI362 Antibodies
Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies.
Measured: From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week)
Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;
Measured: From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;
Measured: From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;
Measured: From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Glucagon of IBI362 in overweight or obesity subjects;
Measured: From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Insulin of IBI362 in overweight or obesity subjects;
Measured: From the first dose (Day 1 ) of study drug until 12 week
Evaluate the C-peptide of IBI362 in overweight or obesity subjects;
Measured: From the first dose (Day 1 ) of study drug until 12 week
Change in body weight from baseline
Measured: Baseline (Day 1 ) and 12 week for groups

Timeline

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

16 Jun 20206 Aug 2021

First posted19 Jun 2020
Study start16 Jun 2020
Primary completion16 Jun 2021
Study completion6 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Overweight or ObesityStudies of the same condition, open and under way.
More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04440345
Sponsor's protocol ID: CIBI362B101
Status last verified: Nov 2023
First submitted: 5 Jun 2020
Last updated: 28 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ji L, Gao L, Jiang H, Yang J, Yu L, Wen J, Cai C, Deng H, Feng L, Song B, Ma Q, Qian L. Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial. EClinicalMedicine. 2022 Oct 7;54:101691. doi: 10.1016/j.eclinm.2022.101691. eCollection 2022 Dec.
PubMed 36247927
Ji L, Jiang H, An P, Deng H, Liu M, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L. IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study. EClinicalMedicine. 2021 Aug 13;39:101088. doi: 10.1016/j.eclinm.2021.101088. eCollection 2021 Sep.
PubMed 34430840

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Overweight or Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obese Subjects
ClinicalTrials.gov ID: NCT04440345
Acronym / sponsor ID: CIBI362B101
Conditions: Overweight or Obesity
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
Study start: 16 Jun 2020 (actual)
Primary completion: 16 Jun 2021 (actual)
Study completion: 6 Aug 2021 (actual)
First posted: 19 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
IBI362	Experimental	Drug: IBI362Participants 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.
placebo	Placebo comparator	Drug: PlaceboParticipants received matching placebo dose regiments by subcutaneous injection

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

Have a diagnosis of type 2 diabetes
Have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening
Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or GCG(glucagon)receptor agonists before.
Surgical treatment for obesity
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IBI362Administered by subcutaneous injection	Drug	IBI362
PlaceboAdministered by subcutaneous injection	Drug	placebo

Primary outcome

Number of treatment adverse events
Time frame: From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)
The relationship of each adverse event to the investigational product was assessed by the investigator.

8 secondary outcomes

Number of Participants With Anti-IBI362 Antibodies
Time frame: From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week)
Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;
Time frame: From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;
Time frame: From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;
Time frame: From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Glucagon of IBI362 in overweight or obesity subjects;
Time frame: From the first dose (Day 1 ) of study drug until 12 week
Evaluate the Insulin of IBI362 in overweight or obesity subjects;
Time frame: From the first dose (Day 1 ) of study drug until 12 week
Evaluate the C-peptide of IBI362 in overweight or obesity subjects;
Time frame: From the first dose (Day 1 ) of study drug until 12 week
Change in body weight from baseline
Time frame: Baseline (Day 1 ) and 12 week for groups

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
Derived from this study: PubMed 36247927Ji L, Gao L, Jiang H, Yang J, Yu L, Wen J, Cai C, Deng H, Feng L, Song B, Ma Q, Qian L. Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial. EClinicalMedicine. 2022 Oct 7;54:101691. doi: 10.1016/j.eclinm.2022.101691. eCollection 2022 Dec.
Derived from this study: PubMed 34430840Ji L, Jiang H, An P, Deng H, Liu M, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L. IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study. EClinicalMedicine. 2021 Aug 13;39:101088. doi: 10.1016/j.eclinm.2021.101088. eCollection 2021 Sep.

Related trials for Overweight or Obesity

Not yet recruitingPhase 3
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RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
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RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IBI362 in people with Overweight or Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site 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 7 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: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of treatment adverse events (time frame: From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)). 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 NCT04440345, which also lists 2 linked publications.

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 28 Nov 2023.