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Type 2 Diabetes Mellitus (T2DM)Phase 2NCT07923357

A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus

A Phase 2 study testing SAL0150 dose 1, SAL0150 dose 2 and SAL0150 dose 3 in people with Type 2 Diabetes Mellitus (T2DM) and Type 2 Diabetes, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a multicenter, randomized, double-blind (with open-lable semaglutide 1.0 mg, active comparator), placebo-and active-controlled, parallel-group Phase 2 clinical trial aimed at evaluating the efficacy, safety and pharmacokinetic (PK) characteristics of SAL0150 tablets in subjects with Type 2 Diabetes… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SAL0150 dose 1, SAL0150 dose 2 and SAL0150 dose 3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
364 participants
Where
1 siteChina
Study dates
30 Oct 2026to 30 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age above or equal to 18 years at the time of signing informed consent;
  • Diagnosed with type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria for diabetes (2011) and classification criteria, and with a disease duration of at least 3 months at screening;
  • Participants who had received any of the following glycemic control regimens prior to screening and had inadequate glycemic control:
  • Diet and exercise intervention alone for at least 8 weeks;
  • Diet and exercise intervention combined with monotherapy with a stable dose of metformin (daily dose ≥ 1000 mg) for at least 6 weeks;
  • HbA1c ≥7.5% and ≤11.0% at screening as assessed by the local laboratory;
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  • Body mass index (BMI) ≥20.0 kg/m2 and ≤42.0 kg/m2 at screening/randomization;
  • No significant change in body weight within 3 months prior to screening (weight gain or loss < 5%);
  • Able to understand the procedures and methods of this study, willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.

Who cannot join

  • Any of the following endocrine-related medical histories or evidence prior to screening:
  • Diagnosis or suspected type 1 diabetes, special types of diabetes (except gestational diabetes) or secondary diabetes;
  • History of acute diabetic complications within 6 months prior to screening, such as diabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis;
  • Having severe chronic complications of diabetes at screening, including but not limited to: proliferative diabetic retinopathy, severe diabetic macular edema, or severe non-proliferative diabetic retinopathy requiring treatment during the study period; intermittent claudication, diabetic foot ulcers; gastroparesis, painful neuropathy, a resting tachycardia, orthostatic hypotension;
  • History of level 3 hypoglycemia within 6 months prior to screening (manifesting as central nervous system symptoms or abnormal changes in mental behavior);
  • Has a personal history or first degree relative family history of multiple endocrine neoplasia syndrome type 2 (MEN2) or medullary thyroid carcinoma (MTC);
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  • Abnormal thyroid function that is not stably controlled with medication at screening (for at least 3 months);
  • Having other serious endocrine system diseases that affect glucose metabolism, such as multiple endocrine neoplasia, Cushing's syndrome, etc.;
  • Any of the following medical history or evidence prior to screening:
  • History of the following serious cardiovascular or cerebrovascular diseases within 6 months prior to screening: such as decompensated heart failure (New York Heart Association [NYHA] functional class III or IV), acute myocardial infarction, unstable angina attacks, or cardiac surgery such as coronary stent implantation or coronary artery bypass grafting (diagnostic angiography is permitted); new-onset stroke, transient ischemic attack, or recurrent syncope;
  • Uncontrolled hypertension during screening: seated systolic blood pressure (SBP) ≥160 mmHg and/or seated diastolic blood pressure (DBP) ≥100 mmHg; or hypotension (SBP <90 mmHg);
  • Have obvious hematologic diseases or any diseases that cause hemolysis or erythrocyte instability, including but not limited to: hemolytic anemia, aplastic anemia, myelodysplastic syndrome, thalassemia, etc.;
  • Have a history of acute or chronic pancreatitis, symptomatic gallbladder or biliary tract disease (such as common bile duct stones, cholelithiasis with multiple stones, etc.; if the common bile duct stones have been cleared or the subject has previously undergone cholecystectomy, may be enrolled after assessment by the investigator), or a history of pancreatic injury and other high-risk factors that may lead to pancreatitis;
  • Have a history of severe gastrointestinal diseases (such as active ulcer, inflammatory bowel disease) occurring within 6 months prior to screening, or have undergone gastrointestinal surgery (except appendectomy, polypectomy or other gastrointestinal endoscopic surgeries that are judged by the investigator to have no significant effect on gastrointestinal motility), or have clinically significant gastric emptying abnormalities(such as pyloric obstruction, intestinal obstruction, etc.), or have been taking drugs that directly affect gastrointestinal motility for a long time(such as domperidone, mosapride, cisapride, etc.);
  • Severe trauma or acute infection within 4 weeks prior to screening that could potentially affect glycemic control;
  • Any of the following clinically significant arrhythmias occurring at screening or randomization: second or third degree atrioventricular block, long QT syndrome, or other severe arrhythmias that the investigator deems unsuitable for inclusion in this study;
  • History of malignant tumor within 5 years prior to screening (except clinically cured local skin basal cell carcinoma or carcinoma in situ); Comorbid psychiatric illness or language barriers, unwilling or unable to adequately understand and cooperate.
  • Use of any of the following medications or treatments prior to screening:
  • Use of glucose-lowering medications other than metformin within 2 months prior to screening (except for cumulative duration ≤7 days);
  • Use of GLP-1RA analogs or related compounds within 3 months prior to screening; known or suspected allergy to the investigational drug or related products; discontinued medication more than 3 months prior to screening due to intolerance or lack of efficacy must also be excluded;
  • Use of weight-loss medications within 3 months prior to screening, or undergoing surgery that could lead to weight instability, or plan to undergo bariatric surgery or weight-loss procedures/surgical treatments during the trial; Currently receiving or having received chronic (>2 weeks) systemic glucocorticoid treatment within 3 months prior to screening (excluding topical, intraocular, intranasal, single intra-articular injection, or inhaled formulations), or having received such treatment within 4 weeks prior to screening.
  • Any of the following laboratory abnormalities at screening:
  • Aspartate aminotransferase (AST) ≥3× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3× ULN;
  • Total bilirubin (TBIL) >1.5× ULN;
  • Amylase and/or lipase ≥ 2×ULN;
  • Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m² (estimated using the CKD-EPI formula) or urinary albumin to creatinine ratio(UACR) ≥ 300 mg/g;
  • Triglycerides (TG) > 5.65 mmol/L;
  • Calcitonin ≥ 50 ng/L;
  • Thyroid-stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L; Positive result on hepatitis B surface antigen (HBsAg) and HBV-DNA quantitative test results above the upper limit of the local laboratory reference range, or positive hepatitis C virus antibody (HCV-Ab) and HCV-RNA test results above the upper limit of the local laboratory reference range, or positive human immunodeficiency virus(HIV) antibody, or positive treponema pallidum antibody.
  • History of substance abuse or alcohol abuse within 6 months prior to screening (consuming 14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine);
  • Participation in a clinical trial of another drug or medical device within 3 months prior to screening, and receipt of investigational medication or medical device intervention;
  • Undergoing major surgical treatment within 3 months prior to screening, or having elective surgery scheduled during the study period (excluding minor surgeries under local anesthesia);
  • Have donated blood or lost ≥400 mL of blood, received blood transfusion or used blood products within 3 months prior to screening; Pregnancy, lactation, or have tested positive for pregnancy; participants or their partners who are unwilling to use effective contraception from the time of signing the informed consent form until 3 months after the last dose.
  • Any other factor that, in the investigator's opinion, may affect the efficacy or safety assessment of this study or make the subject unsuitable for participation in this clinical trial (including, but not limited to, poor compliance as judged by the investigator, or living too far away to attend scheduled follow-up visits).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Linong Ji, M.D contact

00861088325578 ext. 0086108832451

jiln@bjmu.edu.cn

China1 site

  • Peking University People's Hospital

    Beijing, Beijing Municipality

    Linong Ji, M.D, 00861088325578 ext. 0086108832451, jiln@bjmu.edu.cn

Other trials in China

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics Characteristics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus Inadequate Glycemic Control

This study is a multicenter, randomized, double-blind (with open-lable semaglutide 1.0 mg, active comparator), placebo-and active-controlled, parallel-group Phase 2 clinical trial aimed at evaluating the efficacy, safety and pharmacokinetic (PK) characteristics of SAL0150 tablets in subjects with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control after diet and exercise alone or after diet and exercise combined with stable-dose metformin monotherapy.

Read the detailed description

This phase 2, multicenter, randomized, double-blind, placebo-and active-controlled, parallel-group study aims to assess the efficacy, safety and PK characteristics of SAL0150 tablets in adult participants with T2DM inadequately controlled with diet and exercise alone or after diet and exercise combined with stable-dose metformin monotherapy.

The study includes a screening period of approximately 2 weeks, a run-in period of 3 weeks or 6 weeks (placebo, or placebo combined with stable-dose Glucophage XR), a 15-week treatment period, and a 2-week follow-up period, for a total duration of approximately 23 or 26 weeks.

A total of 364 participants will be randomized in this study, and will be stratified according to baseline glycated hemoglobin (HbA1c) (≤ 8.5% or > 8.5%) and background diabetes treatment (diet and exercise alone, or diet and exercise combined with metformin monotherapy). Eligible participants will be randomized 1:1:1:1:1:1:1 to receive different doses of SAL0150, placebo, or open-label semaglutide 1.0 mg (active comparator), with 52 subjects in each treatment group.The primary endpoint is the change from baseline in HbA1c at Week 16.

Being tested
SAL0150 dose 1, SAL0150 dose 2, SAL0150 dose 3, Placebo, Semaglutide inject 1.0 mg
Keywords
type 2 diabetes mellitus, Glucagon-Like Peptide-1 Receptor Agonists, SAL0150
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.

  • SAL0150 dose 1Drug

    SAL0150 tablets, use as specified in the protocol

  • SAL0150 dose 2Drug

    SAL0150 tablets,use as specified in the protocol

  • SAL0150 dose 2Drug

    SAL0150 tablets, use as specified in the protocol

  • SAL0150 dose 3Drug

    SAL0150 tablets, use as specified in the protocol

  • SAL0150 dose 3Drug

    SAL0150 tablets, use as specified in the protocol

  • PlaceboDrug

    Placebo

  • Semaglutide inject 1.0 mgDrug

    Semaglutide inject, 1.0 mg once weekly, 15 weeks

Study groups in NCT07923357
Study groupRoleWhat they receive
SAL0150 group 1ExperimentalSAL0150 tablets, use as specified in the protocol
Receives: Drug: SAL0150 dose 1
SAL0150 group 2ExperimentalSAL0150 tablets, use as specified in the protocol
Receives: Drug: SAL0150 dose 2
SAL0150 group 3ExperimentalSAL0150 tablets, use as specified in the protocol
Receives: Drug: SAL0150 dose 2
SAL0150 group 4ExperimentalSAL0150 tablets, use as specified in the protocol
Receives: Drug: SAL0150 dose 3
SAL0150 group 5ExperimentalSAL0150 tablets, use as specified in the protocol
Receives: Drug: SAL0150 dose 3
Placebo GroupPlacebo comparatorPlacebo
Receives: Drug: Placebo
Semaglutide inject GroupActive comparatorSemaglutide inject, 1.0 mg once weekly, 15 weeks
Receives: Drug: Semaglutide inject 1.0 mg

What is being measured

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

  1. HbA1c

    HbA1c is measured to estimate average plasma glucose concentration

    Measured: Change From Baseline in HbA1c at Week 16(Baseline, Week 16)

Secondary outcomes (2)

  1. HbA1c

    HbA1c is measured to estimate average plasma glucose concentration over the preceding 2-3 months

    Measured: Change from baseline in HbA1c (Baseline, Week 5, Week 9 and Week 13);

  2. Percentage of study participants achieving HbA1c < 7.0%, ≤ 6.5% or ≤ 5.7%

    Percentage of study participants achieving HbA1c < 7.0%, ≤ 6.5% or ≤ 5.7%(Week 16)

    Measured: Change from baseline to Week 16

Timeline

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

  1. First posted6 Nov 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07923357
Sponsor's protocol ID
SAL0150A201
Status last verified
Nov 2026
First submitted
2 Nov 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAL0150 dose 1, SAL0150 dose 2 and SAL0150 dose 3 in people with Type 2 Diabetes Mellitus (T2DM) and Type 2 Diabetes, run by Shenzhen Salubris Pharmaceuticals 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 9 inclusion and 34 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Linong Ji, M.D (00861088325578 ext. 0086108832451, jiln@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Change From Baseline in HbA1c at Week 16(Baseline, Week 16)). 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 NCT07923357.

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 6 Nov 2026.

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