Health TrialsbyHealthPanel

RESET System Pivotal Trial (Rev F)

ConditionsDiabetes type2Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorMorphic Medical Inc.

About this trial

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study.

A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥22 years and ≤ 65 years

Have understood and signed the approved informed consent form

Diagnosis of type 2 diabetes

HbA1c ≥ 7.5% and ≤10%

Disqualifiers

Previous treatment with the RESET System

Previous GI surgery that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner, or abnormal GI anatomical finding that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner

Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance

Known history of liver disease (e.g., viral or autoimmune etiology, METAVIR grade 2 or higher fibrosis/cirrhosis from a biopsy within the past 6 months, but not including incidental fatty liver)

Trial design

Design model

Parallel

Treatments tested in this trial

  • RESET Liner

    Device

    The RESET System is provided as a single-use, sterile device and consists of an RESET Liner preloaded, packaged and sterilized within the RESET Delivery System. The RESET Delivery System is utilized to deliver the RESET Liner to the proximal small intestine. The RESET Liner is removed using the RESET Retrieval System. The RESET System incorporates no pharmacological, biological tissue or blood products.

  • Sham

    Other intervention

    Patient receives upper endoscopy but no treatment

Treatment groups

264 Participants
are divided into 2 treatment groups
Group A: RESETExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in HbA1c

Change in HbA1c value from baseline to 9 months.

Time frame
9 Months

Secondary outcomes

1

HbA1c value

Proportion of patients who achieve an HbA1c value of \< 7 %

Time frame
9 and 21 months
2

Weight Loss

Proportion of patients who achieve percent total body weight loss ≥ 5% from baseline

Time frame
9 and 21 months
3

Insulin use

Proportion of patients reducing insulin dosage

Time frame
9 and 21 months
4

LDL cholesterol

Chnage in LDL cholesterol

Time frame
9 and 21 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Morphic Medical Inc.

Lead sponsor

Biostatistical Consulting, Inc.

Collaborator

Source ClinicalTrials.gov
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