LAPS-Exendin for Type 2 Diabetes

Not currently recruiting at 1 trial location

Overseen By Hanmi Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hanmi Pharmaceutical Company Limited

Disqualifiers: Type 1 diabetes, Retinopathy, Neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called LAPS-Exendin, a potential diabetes medication, to assess its effects on stomach emptying and insulin response in people with type 2 diabetes. Participants will be divided into groups to receive either a weekly, monthly, or daily treatment, or a placebo. The researchers aim to understand how this treatment compares to others and its potential benefits for managing diabetes. Individuals living with type 2 diabetes may be suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LAPS-Exendin, also known as HM11260C, is generally well-tolerated. Studies have found it effective in aiding weight loss and controlling blood sugar levels. Common side effects include mild nausea and vomiting, typical for treatments of this kind. These effects are usually manageable and tend to decrease over time. Earlier studies with similar treatments reported serious side effects as rare. It is important to note that this is a Phase 1 trial, an early stage in testing the treatment's safety and the body's response to it. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

LAPS-Exendin is unique because it offers a new approach to treating Type 2 Diabetes Mellitus by using a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist. Unlike standard treatments such as Metformin, Sulfonylureas, or DPP-4 inhibitors, which require daily dosing and often come with limitations regarding blood sugar control and side effects, LAPS-Exendin is designed to be administered less frequently. This could mean a more convenient treatment regimen and potentially better adherence for patients. Additionally, its long-acting nature may lead to more stable blood sugar levels and improved overall diabetes management, which is why researchers are eager to see the outcomes.

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

Research has shown that LAPS-Exendin, which participants in this trial may receive, could benefit people with Type 2 Diabetes. Studies have found that all doses of LAPS-Exendin significantly lower blood sugar levels and aid in weight loss. In one study, patients experienced meaningful improvements in both blood sugar and weight. The treatment also appears safe, comparable to other drugs in its category. Overall, early results suggest that LAPS-Exendin might be an effective option for managing Type 2 Diabetes. ^{2 3 6 7 8}

Who Is on the Research Team?

Hanmi Clinical

Principal Investigator

California, United States

Are You a Good Fit for This Trial?

Inclusion Criteria

History of type 2 diabetes

Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit

Use of approved methods of contraception

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different doses of HM11260C or liraglutide to assess effects on gastric emptying and beta-cell response

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LAPS-Exendin

How Is the Trial Designed?

Group I: Cohort C Experimental Treatment 1 Intervention

The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg

Group II: Cohort B Experimental Treatment 2 Interventions

The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg

Group III: Cohort A Experimental Treatment 2 Interventions

The weekly treatment of the 6 mg HM11260C or placebo will be maintained

Who Is Running the Clinical Trial?

Hanmi Pharmaceutical Company Limited

Lead Sponsor

Trials

196

Recruited

62,100+

Young Choi

Hanmi Pharmaceutical Company Limited

Chief Medical Officer since 2023

PhD in Pharmacology from Yonsei University

Jae-Hyun Park

Hanmi Pharmaceutical Company Limited

Chief Executive Officer since 2024

MD from Seoul National University

Published Research Related to This Trial

Exendin (9-39) amide (Ex [9-39]) effectively blocks the insulin-releasing action of GLP-1, which is important for managing conditions like alimentary hypoglycaemia.

Importantly, Ex (9-39) does not interfere with insulin secretion triggered by nutrients, suggesting it can be safely used to target GLP-1 without affecting overall insulin control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance of succinic acid dimethyl ester insulinotropic action to exendin (9-39) amide. Cancelas, J., García-Martínez, JA., Villanueva-Peñacarrillo, ML., et al.[2018]

GLP-1 receptor agonists (GLP-1RAs) are effective in reducing A1C levels and promoting weight loss in patients with type 2 diabetes, while posing a minimal risk of hypoglycemia.

The article provides a comprehensive review of safety and tolerability data, particularly focusing on exenatide, the first approved GLP-1RA, including its comparative risks related to hypoglycemia and potential impacts on pancreatic, thyroid, and cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Glucagon-Like Peptide-1 Receptor Agonists Utilizing Data from the Exenatide Clinical Trial Development Program. Peng, H., Want, LL., Aroda, VR.[2018]

A study analyzing 1,164 cases of hypoglycemia linked to glucagon-like peptide-1 receptor agonists (GLP-1RAs) found that lixisenatide had the strongest association with hypoglycemia, indicating a need for caution when prescribing this medication.

The median onset time for hypoglycemia after starting GLP-1RA treatment was 5 days, with a notable hospitalization rate of 56.08% and a fatality rate of 3.53%, highlighting the potential risks associated with these drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglycemia following the use of glucagon-like peptide-1 receptor agonists: a real-world analysis of post-marketing surveillance data. Zhao, Z., Tang, Y., Hu, Y., et al.[2022]

The GLP-1 antagonist exendin 9-39 effectively blocked the insulin-releasing effects of GLP-1 in both laboratory settings and in healthy volunteers, demonstrating its role in glucose regulation.

Infusion of exendin 9-39 led to higher postprandial glucose levels in subjects, indicating that GLP-1 is crucial for maintaining normal blood sugar levels after meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide 1 has a physiological role in the control of postprandial glucose in humans: studies with the antagonist exendin 9-39. Edwards, CM., Todd, JF., Mahmoudi, M., et al.[2022]

In a pilot study involving 9 infants with congenital hyperinsulinism (K(ATP)HI), the GLP-1 receptor antagonist exendin-(9-39) significantly increased fasting blood glucose levels, indicating its potential to help manage hypoglycemia in these patients.

The study suggests that targeting the GLP-1 receptor could be a promising therapeutic approach for treating children with K(ATP)HI, as exendin-(9-39) effectively inhibited insulin secretion in response to amino acids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLP-1 receptor antagonist exendin-(9-39) elevates fasting blood glucose levels in congenital hyperinsulinism owing to inactivating mutations in the ATP-sensitive K+ channel. Calabria, AC., Li, C., Gallagher, PR., et al.[2022]

Citations

1. hanmi.co.kr hanmi.co.kr/hanmi/img/rnd/2015_EASD_(HM11260C).pdf

CA-Exendin-4 (efpeglenatide) Enhances Insulin Secretion ... Conclusion: In summary, all doses of HM demonstrated clinically meaningful improvements in blood glucose and body weight, with higher doses ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6851541/

Body weight management and safety with efpeglenatide in ... Results. Over 20 wk, all doses of efpeglenatide significantly reduced body weight from baseline versus placebo (P < 0.0001), with placebo‐adjusted reductions ...

3. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/pdfdirect/10.1111/dom.14020

Efficacy and safety of onceâ•'monthly efpeglenatide in patients ... Results: All efpeglenatide doses significantly reduced HbA1c versus placebo (P < 0.0001 for all).

4. researchgate.net researchgate.net/publication/284892859_HM11260C_a_new_generation_long_acting_GLP-1R_agonist_with_a_unique_pharmacokinetic_profile_improves_glucose_control_and_GI_tolerability_A_phase_IIa_clinical_trial_in_type_2_diabetes_mellitus

A phase IIa clinical trial in type 2 diabetes mellitus 22 In a previous phase II study (NCT01452451), once-weekly or once-monthly administration of efpeglenatide resulted in significant weight loss ...

5. austinpublishinggroup.com austinpublishinggroup.com/endocrinology-diabetes/fulltext/ajed-v3-id1053.php

Efpeglenatide: A Once Monthly GLP-1 RA in the Pipeline A1C reduction was up to 1.61% for efpeglenatide 4mg weekly compared to 1.38% for liraglutide 1.8 mg daily, with 89% of patients on metformin prior to the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06174779

A Study to Evaluate Efficacy and Safety of HM11260C in ... A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02057172

NCT02057172 | Glycaemic Control of Weekly LAPS- ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

8. withpower.com withpower.com/trial/phase-1-diabetes-mellitus-type-2-11-2013-0831c

A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 ... The article provides a comprehensive review of safety and tolerability data, particularly focusing on exenatide, the first approved GLP-1RA, including its ...