What is the mechanism of action of this treatment?

Common treatments for obesity often work by regulating appetite and energy balance through various metabolic pathways. For instance, Oleoylethanolamide (OEA) activates the peroxisome proliferator-activated receptor-alpha (PPAR-α), which helps reduce food intake and increase fat metabolism. Other treatments may target the endocannabinoid system or gut-brain axis to modulate hunger signals and energy expenditure. These mechanisms are important for obesity patients as they directly influence weight loss and maintenance by addressing the underlying metabolic dysfunctions.

What side effects are associated with this type of intervention?

Common treatments for obesity that regulate appetite and energy balance, such as GLP-1 receptor agonists and phentermine-topiramate, have several known side effects. GLP-1 receptor agonists can cause gastrointestinal issues like nausea, vomiting, and diarrhea. Phentermine-topiramate may lead to side effects including dry mouth, constipation, insomnia, and an increased heart rate. Both treatments require careful monitoring by healthcare providers to manage these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, focusing on appetite regulation and energy balance. Notable examples include liraglutide (Saxenda), a GLP-1 receptor agonist that helps regulate appetite and food intake, and phentermine/topiramate (Qsymia), which combines an appetite suppressant with a medication that increases feelings of fullness. While these drugs do not specifically activate PPAR-α like Oleoylethanolamide (OEA), they similarly target pathways involved in appetite and energy balance to aid in weight loss.

What other types of research exist?

Promising novel alternatives to Oleoylethanolamide (OEA) for obesity treatment include: 1) GLP-1 receptor agonists (e.g., semaglutide), which enhance insulin secretion and reduce appetite. 2) Combination therapies like phentermine-topiramate, which suppress appetite and increase energy expenditure. 3) PCSK9 inhibitors, which are primarily used for cholesterol management but have shown potential in weight management. These alternatives have demonstrated efficacy in clinical trials and are considered promising for obesity treatment in 2024.

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RiduZone for Weight Loss Maintenance

Phase 4

Waitlist Available

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18-45

Be between 18 and 65 years old

Must not have

Medications that affect alertness (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.)

History of metalworking, injury with shrapnel or metal slivers, or major surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 month, 8 month, 16 month

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial tests if OEA, a natural body compound, can help people maintain weight loss by reducing cravings and helping them feel full. Oleoylethanolamide (OEA) has been shown to reduce appetite and body weight in obese people.

Who is the study for?

This trial is for adults aged 18-45 with a BMI over 25 who are comfortable with fMRI procedures and enjoy milkshakes. Participants must be right-handed, English-speaking, and without serious medical conditions, drug abuse history, major psychiatric disorders, or medications affecting alertness.

What is being tested?

The study aims to see if RiduZone (containing OEA) helps maintain weight loss after the LEARN program compared to a placebo. It focuses on individuals who consume high-fat diets and examines how fat intake influences the effects of OEA.

What are the potential side effects?

Potential side effects of RiduZone (OEA) are not detailed in this summary but could include digestive discomfort or changes in appetite. Placebos typically have no active ingredients but can cause perceived side effects due to expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking medications that make me less alert.

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I have worked with metals, had a metal-related injury, or undergone major surgery.

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I have been diagnosed with diabetes.

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I do not have any serious or unstable illnesses.

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I have had a severe head injury with unconsciousness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 month, 8 month, 16 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 month, 8 month, 16 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 month, 8 month, 16 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in absolute body weight

Change in body fat percent

Change in brain response to milkshake

+38 more

Secondary study objectives

Change in 3-day food diary total solid fat intake

Change in Healthy Eating Index (HEI)

Change in saturated fat intake measured by plasma cholesterol

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RiduZone (90% Oleoylethanolamide (OEA))Experimental Treatment1 Intervention

Participants will be randomly assigned to take 2 capsules of RiduZone (each capsule contains 90% OEA) daily for 16 months.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be randomly assigned to take 2 capsules of placebo daily for 16 months.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity often work by regulating appetite and energy balance through various metabolic pathways. For instance, Oleoylethanolamide (OEA) activates the peroxisome proliferator-activated receptor-alpha (PPAR-α), which helps reduce food intake and increase fat metabolism. Other treatments may target the endocannabinoid system or gut-brain axis to modulate hunger signals and energy expenditure. These mechanisms are important for obesity patients as they directly influence weight loss and maintenance by addressing the underlying metabolic dysfunctions.

Role of the endocannabinoid system in metabolic control.