HU6 for Obesity

Overseen By Catherine MacLaren

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Rivus Pharmaceuticals, Inc.

Disqualifiers: Cardiovascular, Cancer, Gastrointestinal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HU6, a potential drug for obesity, to determine its safety and how the body processes it in individuals with obesity. The study will explore different methods of administering HU6, either as tablets or capsules, and its effects when taken with or without food. Individuals with a body mass index (BMI) of 25 or higher and stable health may find this trial suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial investigator.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that HU6 has been tested in individuals with conditions like non-alcoholic fatty liver disease. In these studies, researchers compared HU6 to a placebo, and many participants tolerated it well. Some studies found that 50-58% of those taking HU6 experienced a significant reduction in liver fat. This indicates the drug's effectiveness for many, though some participants might have experienced side effects.

Regarding safety, HU6 has shown promising results in previous studies, with no major safety concerns reported. However, as with any new treatment, some side effects can occur, potentially including mild issues common in drug testing.

Since this trial is in its early phase, it primarily focuses on assessing the safety of HU6. Researchers will carefully monitor participants to identify any potential problems. Joining this trial offers an opportunity to contribute to research while being closely monitored for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for obesity?

Researchers are excited about HU6 for obesity because it introduces a novel approach by targeting mitochondrial uncoupling. Unlike current obesity treatments that often focus on appetite suppression or calorie absorption, HU6 works by increasing energy expenditure at the cellular level. This means it could potentially burn more calories without requiring significant changes in diet or exercise. Additionally, HU6 is being tested in various forms, such as tablets and capsules, offering flexibility in how the drug can be administered daily.

What evidence suggests that HU6 might be an effective treatment for obesity?

Research has shown that HU6 can aid in weight loss. In one study, participants taking HU6 lost about 2.86 kg more than those on a placebo, which contains no active ingredients. This weight loss primarily resulted from losing body fat, not muscle. Another study found that HU6 also reduced belly and liver fat, which is important for health. Overall, HU6 appears promising as a treatment for obesity by reducing fat while preserving muscle. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for children and adults with obesity. Specific details about who can join are not provided, but typically participants must meet certain health criteria and be within a specific age range.

Inclusion Criteria

Body mass index (BMI) ≥ 25 kg/m2 at Screening

Medically stable in the opinion of the investigator based on medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations. Note that Screening abnormalities or findings outside the normal ranges for any clinical assessments that are considered clinically significant by the Investigator (clinical laboratory tests, ECG, vital signs) may be repeated once at the discretion of the Investigator(s), and results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation

Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this clinical protocol.

Exclusion Criteria

Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease as determined by the investigator and if deemed necessary, in consultation with the medical monitor, which may impact safety

Contraindication to IMP or its excipients and/or history of anaphylactic reactions or clinically significant allergic reaction.

I haven't had cancer or chemotherapy in the last 5 years, except for skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HU6 in various formulations to assess safety, tolerability, and pharmacokinetics

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HU6

Trial Overview The study tests the safety and how the body processes HU6, an experimental medication for obesity. It's given in different forms (tablet or capsule) and dosages to see how it works when people eat or don't eat before taking it.

How Is the Trial Designed?

Group I: Experimental: Active Treatment HU6 450 mg tablet Experimental Treatment 1 Intervention

Drug: HU6 450 mg single tablet once daily (QD)

Group II: Experimental: Active Treatment HU6 150 mg x 3 tablets Experimental Treatment 1 Intervention

Drug: HU6 150 mg x 3 tablets QD

Group III: Experimental: Active Treatment HU6 150 mg granulated blend in a capsule × 3 (450 mg total) Experimental Treatment 1 Intervention

Drug: HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD

Group IV: Experimental: Active Treatment HU6 150 mg drug substance in a capsule × 3 (450 mg total) Experimental Treatment 1 Intervention

Drug: HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD

Group V: Experimental: Active Treatment HU6 (150 mg tablet × 2) BID Experimental Treatment 1 Intervention

Drug: HU6 300 mg dose (supplied as HU6 150 mg tablet × 2) BID (q12 hours)

Who Is Running the Clinical Trial?

Rivus Pharmaceuticals, Inc.

Lead Sponsor

Trials

9

Recruited

540+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40072462/

The HuMAIN-HFpEF Randomized Clinical Trial HU6 (vs placebo) significantly decreased weight (between-group difference, -2.86 kg; 95% CI, -4.68 to -1.04 kg; P = .003), total fat mass ( ...

2. prnewswire.com prnewswire.com/news-releases/rivus-pharmaceuticals-announces-positive-topline-results-from-phase-2-m-accel-trial-of-hu6-showing-significant-reductions-in-liver-fat-in-patients-with-mash-302488778.html

Rivus Pharmaceuticals Announces Positive Topline ... Treatment with HU6 significantly reduced body weight, body fat and abdominal visceral fat with preservation of skeletal muscle mass versus placebo and was well ...

3. healio.com healio.com/news/cardiology/20240813/topline-data-show-significant-weight-loss-with-hu6-in-patients-with-obesityrelated-hfpef

Top-line data show significant weight loss with HU6 in ... HU6, a controlled metabolic accelerator, conferred significant weight loss in patients with obesity-related HFpEF. HuMAIN was a double-blind, ...

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/article-abstract/2831126

Novel Controlled Metabolic Accelerator for Obesity-Related ... HU6 (vs placebo) significantly decreased weight (between-group difference, −2.86 kg; 95% CI, −4.68 to −1.04 kg; P = .003), total fat mass ( ...

5. ajmc.com ajmc.com/view/weight-loss-drug-hu6-shows-promise-in-mash-with-muscle-sparing-benefits

Weight Loss Drug HU6 Shows Promise in MASH ... In the M-ACCEL trial, HU6-induced weight loss was exclusively attributed to fat loss, with no statistically significant loss in lean muscle.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37806314/

Safety and efficacy of once-daily HU6 versus placebo in ... We aimed to assess the safety and efficacy of HU6 compared with placebo in people with non-alcoholic fatty liver disease (NAFLD) and high BMI.

7. rivuspharma.com rivuspharma.com/news/press-releases/110725/

Meeting ® 2025 50-58% of patients treated with HU6 achieved a ≥30% reduction in liver fat, which was also statistically significant (p<0.005 for all doses ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04874233

Phase 2a Study of HU6 in Subjects With Elevated Liver Fat ... A 61-day randomized, double blind, placebo-controlled trial to assess the safety and efficacy of three doses of HU6 in subjects with elevated liver fat and ...

9. prnewswire.com prnewswire.com/news-releases/rivus-pharmaceuticals-announces-publication-of-phase-2a-humain-trial-of-hu6-in-patients-with-obesity-related-heart-failure-in-jama-cardiology-302400059.html

Rivus Pharmaceuticals Announces Publication of Phase ... Treatment with HU6 led to significant reductions in body fat and abdominal visceral fat while preserving skeletal muscle in patients with obesity-related heart ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S246812532300198X

Safety and efficacy of once-daily HU6 versus placebo in ... We aimed to assess the safety and efficacy of HU6 compared with placebo in people with non-alcoholic fatty liver disease (NAFLD) and high BMI.