125 Participants Needed

MET097 for Diabesity

(VESPER-2 Trial)

Recruiting at 5 trial locations
MR
Overseen ByMetsera Recruiting
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Metsera
Must be taking: Metformin, SGLT-2
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have stable therapy for at least 30 days before the trial, which suggests you may continue your current treatment if it's stable.

What data supports the effectiveness of the drug MET097 for Diabesity?

Metformin, a component of MET097, is well-established for managing type 2 diabetes by reducing insulin resistance and improving blood sugar control. It also helps with weight reduction, which is beneficial for Diabesity, a condition involving both diabetes and obesity.12345

Is MET097 safe for humans?

Metformin, which may be similar to MET097, is generally considered safe for treating type 2 diabetes. It has been shown to improve blood sugar control and has beneficial effects on heart health, blood pressure, and weight. However, like any medication, it can have side effects, so it's important to discuss with a doctor.46789

How does the drug MET097 differ from other treatments for diabesity?

MET097, also known as metformin, is unique because it not only helps control blood sugar levels but also impacts body composition and reduces inflammation and oxidative stress, which are important factors in managing diabesity (a combination of diabetes and obesity).1011121314

Eligibility Criteria

Adults with obesity or overweight and type 2 diabetes mellitus (T2DM) are eligible for this trial. Participants must be able to receive weekly subcutaneous injections for 28 weeks. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I have had type 2 diabetes for at least 3 months.
BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening
My HbA1c is between 7.0% and 10.5%, and I've been on a stable diabetes treatment for over 30 days.
See 1 more

Exclusion Criteria

I have had a stroke in the past.
Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2
Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL)
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MET097 or placebo via subcutaneous injection once weekly

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • MET097
Trial Overview The study is testing the effectiveness of MET097, an ultra-long-acting GLP-1 receptor agonist, compared to a placebo in managing diabesity. Participants will either get MET097 or a placebo in one of four different dose regimens by chance.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: MET097 Active without titrationExperimental Treatment1 Intervention
Group II: MET097 Active with titrationExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Metsera

Lead Sponsor

Trials
3
Recruited
610+

Findings from Research

The CAIPaDi program, which includes 9 interventions over 7 hours, effectively helped 80.6% of participants achieve an HbA1c level below 7% after the initial 4 visits, indicating strong short-term efficacy in managing type 2 diabetes.
Sustained improvements were observed over 24 months, with 61.0% of patients maintaining HbA1c <7%, and significant enhancements in empowerment and quality of life, while anxiety and depression levels remained low, suggesting the program's holistic approach is beneficial for long-term management.
Long-term effectiveness of a type 2 diabetes comprehensive care program. The CAIPaDi model.Hernández-Jiménez, S., García-Ulloa, AC., Bello-Chavolla, OY., et al.[2019]
A review of 243 elderly patients with type 2 diabetes showed that metformin is safe for long-term use, with no significant changes in liver and renal function or blood lactic acid levels after treatment.
While metformin effectively reduced blood glucose levels in some patients, it was most effective when combined with other medications, indicating that combination therapy may be necessary for better management of diabetes in the elderly.
[Safety of metformin in the treatment of elderly type 2 diabetes mellitus].Tian, H., Li, CL., Yang, G., et al.[2017]
In a study of 14,512 patients with type 2 diabetes, those treated with sulphonylureas (SUs) and thiazolidinediones (TZDs) experienced significantly more adverse events (AEs) compared to those treated with metformin (MET), with rates of 15.9% and 19.8% respectively, versus 8.6% for MET.
While AEs did not significantly affect overall glycaemic control (A1C levels), they did influence treatment patterns, leading to more patients on MET and SU switching therapies or adding additional treatments after experiencing AEs.
Association between oral antidiabetic use, adverse events and outcomes in patients with type 2 diabetes.Asche, CV., McAdam-Marx, C., Shane-McWhorter, L., et al.[2022]

References

Long-term effectiveness of a type 2 diabetes comprehensive care program. The CAIPaDi model. [2019]
Association between residual islet beta-cell function and achieving the target of time in range in inpatients with type 2 diabetes undergoing antidiabetic treatment: An observation study. [2023]
3.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
Two-year effect of rosiglitazone in chinese poorly controlled type 2 diabetic patients. [2018]
Metformin: diamonds are forever. [2013]
[Therapy decision based on the glucose triad. Drug treatment of type 2 diabetes]. [2022]
[Safety of metformin in the treatment of elderly type 2 diabetes mellitus]. [2017]
Association between oral antidiabetic use, adverse events and outcomes in patients with type 2 diabetes. [2022]
[Benefits and risks of current pharmacotherapy in the treatment of type 2 diabetes]. [2021]
Metformin: mechanisms of antihyperglycemic action, other pharmacodynamic properties, and safety perspectives. [2021]
Effects of metformin on the body composition in subjects with risk factors for type 2 diabetes. [2014]
Effect of metformin on oxidative stress, nitrosative stress and inflammatory biomarkers in type 2 diabetes patients. [2022]
[Effect of acupuncture on serum leptin level in patients with type II diabetes mellitus]. [2016]
13.United Statespubmed.ncbi.nlm.nih.gov
Management of type 2 diabetes: new and future developments in treatment. [2022]
Effects of acarbose and metformin on the inflammatory state in newly diagnosed type 2 diabetes patients: a one-year randomized clinical study. [2022]
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