Diabetes Mellitus, Type 2Phase 1NCT06422624

A Study to Evaluate Safety, Tolerability and pK of Semaglutide ER Injectable Suspension in Healthy, Adult Human Subjects

A Phase 1 study testing Semaglutide Extended-release for Injectable Suspension, 1 mg, Semaglutide Extended-release for Injectable Suspension, 4 mg and Semaglutide Extended-release for Injectable Suspension, 8 mg in people with Diabetes Mellitus, Type 2, run by Bostal Drug Delivery Co., Ltd.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 purpose of the trail is to evaluate the safety, tolerability and pharmacokinetics of a single escalated doses of semaglutide extended-release injectable suspension in healthy adult, human study participants under fasting condition. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Semaglutide Extended-release for Injectable Suspension, 1 mg, Semaglutide Extended-release for Injectable Suspension, 4 mg and Semaglutide Extended-release for Injectable Suspension, 8 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: No sites listed yet
Study dates: Aug 2024to Nov 2024
Phase: Phase 1
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

He/She should provide written informed consent.
He/She must be a healthy adult human male or non-pregnant, non-lactating females,18 - 45 years of age (both years inclusive).
He/She should have a body mass index ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 with body weight at least 55 kg for men and at least 48 kg for women.
He/She should have a baseline systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 100 mm Hg. Similarly baseline diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 60 mmHg.
He/She should have pulse rate not less than 60 beats/min and not more than 100 beats/min and respiratory rate not less than 14 breaths/min and not more than 18 breaths/min.
He/She must be of normal health as determined by medical history (including medication history) and physical examination performed within 21 days prior to the dosing.

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He/She should have normal ECG, chest X-ray and vital signs.
He/She should have normal or clinically non-significant thyroid function tests (T3, T4 and TSH).
Availability of a study volunteer for the entire study duration and willingness to adhere to protocol requirements as evidenced by written informed consent.
If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence for the duration of the study as judged by the investigator(s), or If she is postmenopausal with spontaneous amenorrhea for at least 01 year. or If she is surgically sterile (had a bilateral tubal ligation, bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 06 months).

Who cannot join

He/She is incapable of understanding the informed consent.
He/She has a history of hypersensitivity (e.g. anaphylactic reactions, angioedema and serious skin reactions) or idiosyncratic reaction to active or inactive ingredient in the Semaglutide extended-release injectable suspension or any other related drugs.
He/She has a history of impairment of renal, hepatic, cardiac, pulmonary or gastrointestinal function.
He/She has a history of tuberculosis, epilepsy, asthma, diabetes, psychosis and eye disorders.
He/She has history of any pulmonary disorder (COPD, Asthma, Bronchitis, other respiratory disorders) and skin related disorders.
He/She has a personal or family history of Medullary Thyroid Carcinoma (MTC) or any other thyroid tumors or Multiple Endocrine Neoplasia 2 (MEN 2) or any other endocrine disorders.

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He/She has a history of pancreatitis, diabetic retinopathy, gall bladder disease.
He/She has undergone surgery within the past 3 months prior to screening, or those planning to undergo surgery during the trial period.
He/She has any difficulty in swallowing.
He/She regularly smokes more than 10 cigarettes daily or has difficulty in abstaining from tobacco for the entire study duration.
He/She has taken over the counter or prescribed medications, including vitamins, herbal supplements, insulin or drugs which promote insulin secretion, Sulfonylureas, any oral medications or any systemic medication within the past 30 days prior to dosing.
He/She has a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
He/She has a history of alcohol or substance abuse within the last 05 years.
He/she using prohibited medications (e.g., sedative hypnotics, CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating antiepileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants).
He/She has clinically significant abnormal values of laboratory parameters.
He/She has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 90 days.
He/She is unable to or unlikely to be compliant with protocol requirements or restrictions.
He/She, in whom study drug is contraindicated for medical reasons.
He/She is intolerant to venipuncture.
Positive results at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis C Virus (HCV) or syphilis.
Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 06 months prior to study or used oral contraceptives within 14 days before dosing.
Female volunteer who demonstrates a positive pregnancy test.
Female study volunteer who is pregnant, breast-feeding or who is likely to become pregnant during the study.
Female using Hormonal IUD (Mirena), Norplant and other hormones, Depo-Provera, OCPs. (Females of child bearing age will be required to use 2 reliable forms of contraception such as condom and spermicidal or barrier method and spermicidal if sexually active. However, the use of Copper IUD or Tubal ligation are sufficient).

About this study

Official title: An Open Label, Single Dose, Dose Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Semaglutide Extended-release Injectable Suspension in Normal Healthy, Adult, Human Study Participants Under Fasting Condition

Conditions: Diabetes Mellitus, Type 2
Being tested: Semaglutide Extended-release for Injectable Suspension, 1 mg, Semaglutide Extended-release for Injectable Suspension, 4 mg, Semaglutide Extended-release for Injectable Suspension, 8 mg
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

Semaglutide Extended-release for Injectable Suspension, 1 mgDrug
Singel-dose; Subcutaneous
Semaglutide Extended-release for Injectable Suspension, 4 mgDrug
Singel-dose; Subcutaneous
Semaglutide Extended-release for Injectable Suspension, 8 mgDrug
Singel-dose; Subcutaneous

Study groups in NCT06422624
Study group	Role	What they receive
Semaglutide ER Injectable Suspension, 1 mg	Experimental	Participants receive a single of semaglutide ER injectable suspension at a lower dose 1 mg for safety, tolerability and pharmacokinetics assessements Receives: Drug: Semaglutide Extended-release for Injectable Suspension, 1 mg
Semaglutide ER Injectable Suspension, 4 mg	Experimental	Participants receive a single of semaglutide ER injectable suspension at a medium dose 4 mg for safety, tolerability and pharmacokinetics assessements Receives: Drug: Semaglutide Extended-release for Injectable Suspension, 4 mg
Semaglutide ER Injectable Suspension, 8 mg	Experimental	Participants receive a single of semaglutide ER injectable suspension at a higher dose 8 mg for safety, tolerability and pharmacokinetics assessements Receives: Drug: Semaglutide Extended-release for Injectable Suspension, 8 mg

What is being measured

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

Cmax
Maximum plasma concentration
Measured: From time zero up to the last time point with measurable concentration
AUC0-t
Area under the plasma concentration time curve from time zero to the last measurable concentration
Measured: From time zero up to the last time point with measurable concentration
AUC0-inf
Area under the plasma concentration-time curve from time zero to infinity
Measured: From time zero up to the last time point with measurable concentration

Timeline

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

Aug 2024Nov 2024

First posted21 May 2024
Study startAug 2024 (estimated)
Primary completionNov 2024 (estimated)
Study completionNov 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 14 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06422624
Sponsor's protocol ID: 15403/23-24
Status last verified: May 2024
First submitted: 15 May 2024
Last updated: 22 May 2024
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

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?

Official record

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Single Dose, Dose Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Semaglutide Extended-release Injectable Suspension in Normal Healthy, Adult, Human Study Participants Under Fasting Condition
ClinicalTrials.gov ID: NCT06422624
Acronym / sponsor ID: 15403/23-24
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 14 participants (estimated)
Lead sponsor: Bostal Drug Delivery Co., LtdIndustry (pharma, biotech, devices)
Study start: Aug 2024 (estimated)
Primary completion: Nov 2024 (estimated)
Study completion: Nov 2024 (estimated)
First posted: 21 May 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Semaglutide ER Injectable Suspension, 1 mg	Experimental	Drug: Semaglutide Extended-release for Injectable Suspension, 1 mgParticipants receive a single of semaglutide ER injectable suspension at a lower dose 1 mg for safety, tolerability and pharmacokinetics assessements
Semaglutide ER Injectable Suspension, 4 mg	Experimental	Drug: Semaglutide Extended-release for Injectable Suspension, 4 mgParticipants receive a single of semaglutide ER injectable suspension at a medium dose 4 mg for safety, tolerability and pharmacokinetics assessements
Semaglutide ER Injectable Suspension, 8 mg	Experimental	Drug: Semaglutide Extended-release for Injectable Suspension, 8 mgParticipants receive a single of semaglutide ER injectable suspension at a higher dose 8 mg for safety, tolerability and pharmacokinetics assessements

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

He/She should provide written informed consent.
He/She must be a healthy adult human male or non-pregnant, non-lactating females,18 - 45 years of age (both years inclusive).
He/She should have a body mass index ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 with body weight at least 55 kg for men and at least 48 kg for women.
He/She should have a baseline systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 100 mm Hg. Similarly baseline diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 60 mmHg.
He/She should have pulse rate not less than 60 beats/min and not more than 100 beats/min and respiratory rate not less than 14 breaths/min and not more than 18 breaths/min.

Key exclusion criteria (24 listed)

He/She is incapable of understanding the informed consent.
He/She has a history of hypersensitivity (e.g. anaphylactic reactions, angioedema and serious skin reactions) or idiosyncratic reaction to active or inactive ingredient in the Semaglutide extended-release injectable suspension or any other related drugs.
He/She has a history of impairment of renal, hepatic, cardiac, pulmonary or gastrointestinal function.
He/She has a history of tuberculosis, epilepsy, asthma, diabetes, psychosis and eye disorders.
He/She has history of any pulmonary disorder (COPD, Asthma, Bronchitis, other respiratory disorders) and skin related disorders.

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
Semaglutide Extended-release for Injectable Suspension, 1 mgSingel-dose; Subcutaneous	Drug	Semaglutide ER Injectable Suspension, 1 mg
Semaglutide Extended-release for Injectable Suspension, 4 mgSingel-dose; Subcutaneous	Drug	Semaglutide ER Injectable Suspension, 4 mg
Semaglutide Extended-release for Injectable Suspension, 8 mgSingel-dose; Subcutaneous	Drug	Semaglutide ER Injectable Suspension, 8 mg

Primary outcome

Cmax
Time frame: From time zero up to the last time point with measurable concentration
Maximum plasma concentration
AUC0-t
Time frame: From time zero up to the last time point with measurable concentration
Area under the plasma concentration time curve from time zero to the last measurable concentration
AUC0-inf
Time frame: From time zero up to the last time point with measurable concentration
Area under the plasma concentration-time curve from time zero to infinity

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.

Related trials for Diabetes Mellitus, Type 2

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Active, not recruiting
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Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 24 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 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.

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?

Cmax (time frame: From time zero up to the last time point with measurable concentration). The study lists 3 primary outcomes in all. 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 NCT06422624.

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 22 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.