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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06104358
• Other study ID #: RIV-HU6-204
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 17, 2023
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Rivus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Obesity
• Overweight

Intervention

Drug:
• HU6
HU6 is being evaluated for its effect on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function

Locations

Country	Name	City	State
United States	AdventHealth Translational Research Institute	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Rivus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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