What is the mechanism of action of this treatment?

Common treatments for obesity, such as the GOLO for Life® Plan (G4LP) and Release supplementation, work by reducing caloric intake, improving metabolic function, and enhancing fat oxidation. Dietary interventions focus on nutrient-dense, low-calorie foods to create a caloric deficit, essential for weight loss. Supplements may help regulate blood sugar levels, reduce appetite, and increase energy expenditure. These mechanisms are crucial for obesity patients as they offer a comprehensive approach to weight management, addressing both dietary habits and metabolic health, leading to sustainable weight loss and improved overall health.

What side effects are associated with this type of intervention?

Common treatments for obesity, including dietary and supplemental interventions like the GOLO for Life® Plan (G4LP) and Release supplementation, generally aim to improve weight loss and body composition. Known side effects of these treatments can include gastrointestinal issues such as nausea, diarrhea, and constipation. Pharmacological treatments like GLP-1 agonists (e.g., liraglutide) may also cause similar gastrointestinal symptoms, along with potential risks of pancreatitis and gallbladder disease. SGLT2 inhibitors can lead to urinary tract infections and genital infections. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate and safe treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity that focus on weight loss and body composition improvement through dietary and supplemental interventions. Notably, GLP-1 receptor agonists such as liraglutide (Saxenda) and semaglutide (Wegovy) have been approved for weight management in individuals with obesity. These medications work by mimicking the hormone GLP-1, which helps regulate appetite and food intake. Additionally, lifestyle interventions, including dietary changes and physical activity, are often recommended in conjunction with these medications to enhance weight loss and improve overall health.

What other types of research exist?

Promising alternatives for obesity treatment in 2024 include: 1) Subcutaneous infusion of GLP-1, oxyntomodulin (OXM), and peptide YY (PYY), which has shown to reduce energy intake and improve body weight and glycemia in obese patients with prediabetes/diabetes. 2) GLP-1 receptor agonists like extended-release exenatide and dulaglutide, which have demonstrated significant improvements in glycemic control and modest weight loss in clinical trials. 3) Bariatric surgery, such as Roux-en-Y gastric bypass (RYGB), which remains highly effective for significant and sustained weight loss and improvement in metabolic parameters.

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Dietary Supplement

GOLO for Life® Plan + Release for Weight Management in Obesity

Phase 2

Waitlist Available

Led By David Crowley, MD

Research Sponsored by Golo

Eligibility Criteria Checklist

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

Must have

Males and females between the age of 18-65 years, inclusive, at screening

Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening

Must not have

Gastric bypass surgery or other surgeries to induce weight loss

Current or history of significant diseases of the gastrointestinal tract, as assessed by the QI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 90, day 180

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a diet plan called GOLO for Life® (G4LP) combined with a supplement named Release. It aims to help overweight and obese adults lose weight and improve their health. The diet plan encourages healthy eating and lifestyle changes, while the supplement helps control hunger and boost metabolism.

Who is the study for?

Adults aged 18-65 with a BMI of 25-39.9, not pregnant or planning pregnancy, and non-smokers can join this weight management trial. They must be willing to follow the GOLO for Life Plan, use approved birth control if applicable, and have had stable body weight recently.

What is being tested?

The study tests the GOLO for Life Plan with Release supplement's effectiveness on weight loss and health markers like body fat percentage over six months. Participants' progress is tracked using DEXA scans and other measurements.

What are the potential side effects?

Potential side effects are not specified but will be monitored through reports of adverse events during the trial to ensure safety and tolerability of the GOLO for Life Plan and Release supplement.

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 65 years old.

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I cannot have children because I've had surgery or have been menopausal for over a year.

Exclusion Criteria

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

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I have had surgery to help me lose weight.

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I have a history of serious stomach or intestine diseases.

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I have type 2 diabetes and am being treated with insulin.

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I have had a gout flare-up within the last year.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 90, day 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 90, day 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 90, day 180 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The change in fat mass (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release.

The change in fat mass (percent) following the GOLO for Life® Plan (G4LP) and supplementation with Release.

The change in weight (kilograms) following the GOLO for Life® Plan (G4LP) and supplementation with Release.

+1 more

Secondary study objectives

The change in gastrointestinal symptoms from baseline at Days 90 and 180 following the G4LP and supplementation with Release.

The change in lipid levels from baseline at Days 90 and 180 following the G4LP and supplementation with Release.

The change in physical activity from baseline at Days 90 and 180 following the G4LP and supplementation with Release.

+2 more

Other study objectives

Clinically relevant changes in electrolytes after 180 days.

Clinically relevant changes in white blood cell (WBC) count with differential after 180 days.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Golo for Life® Plan(G4LP) and Release SupplementExperimental Treatment1 Intervention

Participants will be instructed to use the resources provided and follow the G4LP for the duration of the study period. Participants will also take one capsule of Release three times a day, to be taken at the beginning of or during each meal, starting on Day 1. If a dose is missed before or during a meal, participants are instructed to take the dose as soon as they remember after the meal. Participants will be advised not to exceed three capsules daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Release

2023

Completed Phase 2

~90

0 / 7Eligibility 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, such as the GOLO for Life® Plan (G4LP) and Release supplementation, work by reducing caloric intake, improving metabolic function, and enhancing fat oxidation. Dietary interventions focus on nutrient-dense, low-calorie foods to create a caloric deficit, essential for weight loss. Supplements may help regulate blood sugar levels, reduce appetite, and increase energy expenditure. These mechanisms are crucial for obesity patients as they offer a comprehensive approach to weight management, addressing both dietary habits and metabolic health, leading to sustainable weight loss and improved overall health.

Novel approaches to anti-obesity drug discovery with gut hormones over the past 10 years.The Effect of a Subcutaneous Infusion of GLP-1, OXM, and PYY on Energy Intake and Expenditure in Obese Volunteers.Is there a path for approval of an antiobesity drug: what did the Sibutramine Cardiovascular Outcomes Trial find?