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

A 6-Month, Randomized, Double-Blind, Placebo-controlled, Phase 2a Study of the Effects of HU6 on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function in Subjects Who Are Overweight or Obese With Type 2 Diabetes

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Diabete Type 2
• Intervention / Treatment: Drug: HU6

Detailed Description

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 (Figure 1).

• Stage 1: (screening) is conducted over a 29-day window (Day -48 to Day -20). Subjects who meet all of the eligibility criteria may proceed Stages 2 to 4 of the study.
• Stage 2 (baseline [pre-randomization]) is conducted over a 19-day period prior to randomization and includes a 13-day run-in and the first 6-day inpatient assessment period. At the end of Stage 2, subjects will be randomized 1:1 to HU6 or placebo.
• Stage 3 (double-blind dosing) is conducted after randomization. Day 1 is the first dose of double-blind study drug, and dosing continues over an approximate 26-week period. During this time, there will be study visits for safety, PK, and PD. Stage 3 of the study concludes with a 3-day run-in followed by the second 6-day inpatient assessment period.
• Stage 4 (washout) is conducted after dosing has ended and includes an approximate 4-week washout duration including a 3-day run-in followed by the third inpatient assessment period (3-day duration). The last day of the 3-day inpatient stay is the end-of-study. (Note that there will be a separate early termination visit for any subject who prematurely discontinues from the study

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • AdventHealth Translational Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment HU6; Subjects who are randomized to active study drug will receive 450mg of HU6 for 14 day and then 600mg of HU6 for 168 days. N = 24	Drug: HU6; HU6 is being evaluated for its effect on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function
Placebo Comparator: Placebo; Placebo Comparator is non-active study drug. N = 24	Drug: HU6; HU6 is being evaluated for its effect on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleeping Metabolic Rate (SMR) change from Baseline to 6 Months (26 weeks)	Change from baseline in SMR at 6 months (26 weeks) as assessed by whole room indirect calorimetry (WRIC).	26 weeks

Collaborators and Investigators

• Sponsor: Rivus Pharmaceuticals, Inc.
• Investigators: Study Director: Rachel Garner, PhD, Rivus Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus, Type 2; Overweight
• Other Study ID Numbers: RIV-HU6-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No