40 Participants NeededMy employer runs this trial

HMS1005 for Type 2 Diabetes

JO
Overseen ByJesus Olivia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HMS1005 for individuals with Type 2 Diabetes. The researchers aim to assess the treatment's safety and its effects in the body. Participants will receive varying doses of HMS1005 or a placebo to compare outcomes. This trial may suit those managing Type 2 Diabetes with diet, exercise, or stable medication and who have not experienced serious diabetes-related complications recently. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

You may need to stop certain medications before joining the trial. Specifically, you cannot use insulin, sulfonylureas, GLP-1 agonists, DPP-4 inhibitors, SGLT2 inhibitors, and glinides. Additionally, certain other medications affecting liver enzymes must be stopped for a specified period before the trial.

Is there any evidence suggesting that HMS1005 is likely to be safe for humans?

Research has shown that HMS1005 has been tested for safety and tolerability in individuals with Type 2 diabetes and healthy participants. The most common side effect was a decrease in appetite, which most people managed well. No serious side effects were reported in these studies, suggesting that HMS1005 is generally well-tolerated.

This trial is in its early stage, known as Phase 1, focusing primarily on assessing safety in a small group of participants. This phase is crucial for identifying any potential side effects before testing the treatment in larger groups. If HMS1005 were not safe for humans, it would not have progressed to this stage.12345

Why do researchers think this study treatment might be promising for diabetes?

Unlike standard treatments for type 2 diabetes, which often rely on insulin or drugs like metformin to manage blood sugar levels, HMS1005 offers a novel approach. Researchers are excited about HMS1005 because it potentially targets a new pathway to regulate glucose, which could improve blood sugar control in a different way. Additionally, HMS1005 is administered in a tablet form with varying doses, providing flexibility in dosing that might enhance patient adherence and outcomes. This innovative treatment could offer new hope for better managing type 2 diabetes.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that HMS1005 offers promising results for managing type 2 diabetes. Earlier studies suggest that HMS1005 helps the body control blood sugar levels more effectively. In animal studies, HMS1005 effectively managed both diabetes and weight. The treatment is designed to last longer in the body, potentially aiding regular medication adherence. These early findings indicate that HMS1005 could be a helpful option for those managing type 2 diabetes.34567

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with type 2 diabetes, a BMI between 18 and 38, fasting blood sugar between 126–240 mg/dL, and HbA1c between 7.0%–10.5%. Participants should be generally healthy aside from diabetes and can be on stable diabetes medications or just diet/exercise.

Inclusion Criteria

8. Fasting plasma glucose between 126 and 240 mg/dL, inclusive. Testing may be repeated once, at the discretion of the Investigator (or designee).
I understand the study and am willing to sign consent and follow its rules.
2. Body mass index between 18 and 38.0 kg/m2, inclusive.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive multiple ascending doses of HMS1005 or placebo to evaluate safety, pharmacokinetics, and pharmacodynamics

19 days
Daily visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • HMS1005

Trial Overview

The study tests different doses of a new drug called HMS1005 compared to a placebo in people with type 2 diabetes. The main goal is to see how safe the drug is and how it behaves in the body.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: 492 mg HMS1005 (2 x 246 mg tablet) and matching placeboExperimental Treatment2 Interventions
Group II: 369 mg HMS1005 (2 x 184.5 mg tablet) and matching placeboExperimental Treatment2 Interventions
Group III: 246 mg HMS1005 (1 x 246 mg tablet) or placeboExperimental Treatment2 Interventions
Group IV: 184.5 mg HMS1005 (1 x 184.5 mg tablet) and matching placeboExperimental Treatment2 Interventions
Group V: 123 mg HMS1005 (1 x 123 mg tablet) and matching placeboExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hua Medicine Limited

Lead Sponsor

Trials
16
Recruited
3,800+

TigerMed

Industry Sponsor

Trials
4
Recruited
1,100+

Citations

NCT07279194 | Efficacy and Safety of HDM1005 in ...

Efficacy and Safety of HDM1005 Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related ...

HMS1005 in Type 2 Diabetes - Clinical Trials Registry

The study is to assess the safety, pharmacokinetics, and pharmacodynamic profile of HMS1005 in patient with diabetes.

[News] Hua Medicine Initiated Phase Ib Clinical Trial of 2nd ...

HMS1005 is expected to prolong the drug's action time in the human body, improve patient medication adherence, and provide the possibility of ...

Efficacy and Safety of HDM1005 Compared to Tirzepatide ...

This is a 56-week randomized, open-label, controlled study evaluating the efficacy and safety of the HDM1005 compared to tirzepatide in ...

HMS1005 for Type 2 Diabetes

This Phase 1 medical study run by Hua Medicine Limited is evaluating whether HMS1005 will have tolerable side effects & efficacy for patients with ...

A Phase 1, Multiple Ascending Dose Study to Evaluate ...

... Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS1005 in Participants With Type 2 Diabetes. Conditions. Type 2 Diabetes. Type ...

142-OR: Safety, Tolerability, Pharmacokinetics (PK), and ...

Results: The most common AEs with HDM1005 were decreased appetite and ... Subtypes of Type 2 Diabetes Determined From Clinical Parameters.