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ACTIVE_NOT_RECRUITINGPHASE2

REducing Diabetic MacrovascUlar Complications DuE to Peripheral Arterial Disease- REDUCE-PAD

NCT05912218•National Heart Centre Singapore

Summary

This is a Phase IIa, multi-centre study conducted at 3 sites in Singapore (SGH and NUHS, KTPH). 70 patients with diabetes mellitus (DM) and peripheral arterial disease (PAD) will be randomised in a ratio 1:1 to receive normal saline control or MEDI6570 400mg by monthly subcutaneous injection for 9 months.

Detailed Description

This is a mechanistic, randomised, double-blind, controlled Phase IIa trial that investigates whether 9 months of treatment with MEDI6570 affects lower limb microvascular perfusion and atheroma inflammation and progression. Patients with both DM and PAD will receive monthly subcutaneous injections of 400mg MEDI6570 (in an injection volume of 4.0ml), or injection/volume-matched normal saline control (4.0ml) subcutaneously, every 4 weeks for 32 weeks (9 doses in total). Com Approximately 70 participants will be randomly assigned to a study intervention, with an anticipated 35 participants being randomized to receive active study intervention, and 35 participants being randomized to receive normal saline control. The primary objective of the study is to determine whether monthly subcutaneous injections of MEDI6570 for 9 months reduces lower limb atheroma plaque inflammation and improves lower limb microvascular perfusion, when compared to normal saline control. The primary endpoint in REDUCE-PAD will be the between-group difference (intervention vs. normal saline control) in the change in PET and MRI scan parameters from baseline to 9 months. Efficacy, safety, PK, and immunogenicity of MEDI6570 will also be evaluated in this study.

Eligibility

Age

21 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomisation, and must adhere to the schedules of activities.
•2. Men must be ≥ 21 years of age at the time of signing the ICF. Women must be ≥ 40 years of age at the time of signing the ICF. For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening Visit 1 by one of the following:
•1. Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range.
•2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.
•3. Participant must have body mass index within the range 18 to 40 kg/m2 inclusive.
•4. Participants must have moderate stable PAD (ABI \< 0.7 and/or TBI \< 0.5) with no prior history of lower limb revascularisation or ulcers.
•5. On stable medical therapy for type 2 DM for at least 6 weeks prior to screening with no clinically significant dose change and/or new medications in the recent 6 weeks
•6. All male participants should refrain from fathering a child or donating sperm during the study and for 190 days following the last dose. Non-sterilised male study participants should be advised to use a condom for all sexual intercourse with a female partner of childbearing potential from Day 1 through the end of the study follow-up period.

Exclusion Criteria

•1. History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
•2. Uncontrolled Type 1 or Type 2 diabetes defined as haemoglobin A1c (HbA1c) \>10%.
•3. Increased risk of bleeding
•1. Patients with history or presence of any bleeding disorder.
•2. Signs of ongoing bleeding at screening (e.g., identified macroscopic bleeding, low haemoglobin presumed to be caused by bleeding) or high risk for major bleeding in accordance with the Investigator's assessment.
•3. . Need for chronic therapeutic anticoagulation therapy anticipated to be required throughout the course of the study (short-term treatment with prophylactic doses of heparin/low molecular weight heparin are allowed).
•4. Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy).
•4. History or presence of any of the following:
•1. Cancer within 5 years before randomization, except for non-melanoma skin cancer.
•2. Alcohol or substance abuse within 6 months before randomization, as judged by the investigator.
+17 more criteria

Locations (1)

Prof Derek J. Hausenloy

Singapore, Singapore, Singapore

Key Dates

Start Date

November 2, 2023

Primary Completion Date

September 1, 2025

Completion Date

December 1, 2025

Last Updated

November 21, 2024

Enrollment

ESTIMATED participants

Conditions

Diabetes Mellitus, Type 2Peripheral Arterial Disease

Interventions

MEI6570

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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REducing Diabetic MacrovascUlar Complications DuE to Peripheral Arterial Disease- REDUCE-PAD

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

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VITUS Post-Market Registry

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion