CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 100 target
Drug / intervention
Releasedietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05844644
NCT05844644Phase 2RecruitingUpdate OverdueUpdated 23mo ago · Completion was 19mo ago
Enrollment Stalled
Long Recruiting
Update Overdue

An Open Label Study Evaluating the Effects of the GOLO for Life® Plan With Release Supplement on Glycemic Control and Weight in Overweight and Obese Adults With Prediabetes or Type 2 Diabetes

Golo·interventional·Posted May 6, 2023·Updated Jul 26, 2024

In Brief

A Phase 2 clinical trial evaluating Release for Type 2 Diabetes and 3 related conditions. Currently recruiting, targeting 100 participants across 2 sites.

Signals

Enrollment appears stalled

Detailed Summary

The objective of this study is to investigate the efficacy and safety of the GOLO for Life® Plan (G4LP) and Release supplementation on glycemic control and weight in overweight and obese adults with Prediabetes or Type 2 Diabetes. The change in glycemic control from baseline at Days 90 and 180 following the G4LP and supplementation with Release will be assessed. Additionally, the safety and tolerability of the G4LP and Release supplementation will be measured by the occurrence of and/or changes in pre-emergent and post-emergent adverse events (AEs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsKGK Science Inc.

Timeline

Phase 2RecruitingOverdue
202420252026
First PostedMay 6, 2023
Enrollment StartApr 20, 2023
Primary CompletionNov 1, 2024
Study CompletionJan 1, 2025
TodayJul 1, 2026
Enrollment to primary: 1.5 yearsPosted 3.2 years ago

Interventions

Releasedietary

One capsule of Release will be taken three times per day for 180 days in combination with the G4LP.