Ph 2a Study of HU6 on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function in Subjects Who Are Overweight or Obese With Type 2 Diabetes

• Status: Withdrawn
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled parallel group study of HU6 and placebo in subjects who are overweight or obese with T2D.

The study will be conducted in 4 stages.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rivus Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

1. Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.

2. Willing and able to comply with the requirements of the study protocol.

3. Male or female 18 to 70 years of age, inclusive, at time of informed consent.

4. Body mass index (BMI) >28.0 kg/m2 and able to fit into the MRI machine.

5. Subject has T2D meeting all of the following criteria:

Exclusion Criteria:

1. Body weight >450 pounds.

2. Subject-reported history of weight gain or loss >5% in 3 months prior to screening.

3. The subject participates in programmed exercise >3 hours per week.