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IGOB131 As A GLP-1 Modulator For Metabolic Disorders In Adults With Obesity

Randomized, Double-Blind, Placebo-controlled Trial Of IGOB131 As A GLP-1 Modulator For Metabolic Disorders In Adults With Obesity

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07884058
Enrollment
80
Registered
2026-10-20
Start date
2026-12-01
Completion date
2027-12-01
Last updated
2026-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity & Overweight

Keywords

GLP-1, DPP-4, obesity, insulin resistance, inflammation, nutraceutical

Brief summary

This clinical trial will investigate the effect of standardized Irvingia gabonensis extract (IGOB131) on GLP-1 dynamics, DPP-4 activity, metabolic parameters, and inflammatory markers in adults with obesity. The study will compare IGOB131 to a placebo to find out if it exerts any significant metabolic benefits through GLP-1 and DPP-4 modulation, and the reduction of adiposity and systemic inflammation. Participants will: Take IGOB131 or a placebo every day for 16 weeks Visit the clinic once every 4 weeks for checkups and tests

Detailed description

Obesity is a complex, chronic disease characterized by excessive adiposity and associated with a markedly increased risk of Type 2 Diabetes, cardiovascular disease, and systemic inflammation. Its global prevalence continues to rise, imposing a substantial burden on healthcare systems and underscoring the urgent need for safe, effective, and accessible therapeutic strategies. While lifestyle modification remains the cornerstone of management, long-term adherence and sustained efficacy are often limited, prompting increasing interest in targeted metabolic interventions. Among emerging therapeutic targets, the incretin system, particularly Glucagon-like peptide-1 (GLP-1), has gained considerable attention. GLP-1 is an intestinal hormone secreted by enteroendocrine L-cells in response to nutrient intake and plays a central role in glucose homeostasis and energy balance. It enhances glucose-dependent insulin secretion, suppresses glucagon release, delays gastric emptying, and promotes satiety. However, the biological activity of endogenous GLP-1 is short-lived due to rapid degradation by Dipeptidyl peptidase-4 (DPP-4), a widely expressed serine protease that cleaves incretin hormones, limiting their physiological effects. Pharmacological targeting of the incretin axis has evolved rapidly in recent years, with GLP-1 receptor agonists emerging as transformative therapies for obesity and metabolic disease. Agents such as semaglutide and liraglutide have demonstrated clinically meaningful and sustained weight loss in both randomized trials and real-world settings, with semaglutide achieving greater reductions compared to liraglutide over one year in clinical practice. Furthermore, recent systematic reviews and meta-analyses confirm that GLP-1 receptor agonists produce significant reductions in body weight, glycemic indices, and cardiometabolic risk factors across diverse populations. In parallel, DPP-4 inhibitors such as sitagliptin enhance endogenous incretin activity by preventing GLP-1 degradation, although their metabolic effects are generally more modest and weight-neutral. Despite the clinical success of incretin-based pharmacotherapies, their use may be limited by cost, accessibility, and tolerability, particularly in low- and middle-income settings. These limitations have intensified interest in alternative strategies capable of modulating the incretin system through physiological and potentially more accessible mechanisms. Nutraceutical approaches represent a promising avenue in this context. Bioactive plant-derived compounds have been shown to influence metabolic pathways involved in appetite regulation, glucose metabolism, and inflammation. IGOB131, a standardized botanical extract derived from Irvingia gabonensis, has been developed for metabolic health, with prior clinical studies demonstrating improvements in body weight, lipid profile, and glycemic control. However, its potential role in modulating incretin physiology-particularly GLP-1 secretion and DPP-4 activity-remains insufficiently characterized. Beyond metabolic dysregulation, obesity is increasingly recognized as a state of chronic low-grade inflammation driven by adipose tissue expansion and immune cell activation. Pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute to insulin resistance and cardiometabolic risk. Notably, recent evidence indicates that GLP-1-based therapies exert pleiotropic effects beyond glycemic control, including anti-inflammatory actions and benefits across multiple organ systems. Additionally, emerging mechanistic and translational studies highlight the expanding role of GLP-1 signalling in immunometabolic regulation and multi-organ protection. This study is designed to investigate the effects of IGOB131 on key components of metabolic regulation in adults with obesity. Specifically, the impact of IGOB131 on fasting and postprandial GLP-1 levels, DPP-4 activity, anthropometric indices, glycemic parameters, and inflammatory markers will be evaluated in a randomised, double-blind, placebo-controlled trial. The investigators hypothesise that IGOB131 may enhance GLP-1 bioavailability through dual mechanisms-stimulating endogenous secretion and reducing enzymatic degradation-thereby improving metabolic and inflammatory outcomes.

Interventions

IGOB-131 is an encapsulated, standardized botanical extract derived from Irvingia gabonensis.

Placebo capsules containing 400 mg of dextrin, looking identical to IGOB131 capsules

Sponsors

University of Yaounde 1
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Males and females with BMI between 25 and 34 kg/m² * Participants aged 18 to 65 years old * Participants willing to comply with the study protocol

Exclusion criteria

* Participants younger than 18 years or older than 65 years * Participants not available for the study period * Morbid obesity (BMI \> 34.9 kg/m²) * Diabetes mellitus requiring daily insulin management * Pregnancy or breastfeeding * Active infection * Systemic diseases, including HIV/AIDS, Active hepatitis, Clinical signs of active malignancy within the past 5 years * Use of any medication or natural health product that might affect the parameters of interest in this study

Design outcomes

Primary

MeasureTime frameDescription
Effect of IGOB131 on postprandial GLP-1 response (0-180 minutes)16 weeksPostprandial GLP-1 responses will be assessed at baseline and week 16 following ingestion of a standardized test meal. Blood samples will be collected at 0 (fasting), 30, 60, 90, 120, 150, and 180 minutes post-meal.
Effect of IGOB131 on fasting plasma GLP-1 concentrations16 weeksBlood samples will be collected at 0 (fasting), 30, 60, 90, 120, 150, and 180 minutes post-meal. Plasma GLP-1 concentrations will be measured using a validated enzyme-linked immunosorbent assay (ELISA).
Effect of IGOB131 on DPP-4 enzymatic activity16 weeksFasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). DPP-4 activity will be determined using a colorimetric assay based on enzymatic cleavage of a specific substrate.

Secondary

MeasureTime frameDescription
Effect of IGOB131 on fasting blood glucose16 weeksFasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). Fasting glucose will be measured using the glucose oxidase method.
Effect of IGOB131 on fasting insulin16 weeksFasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). Fasting insulin concentrations will be measured by immunoassay.
Effect of IGOB131 on glycated hemoglobin (HbA1c)16 weeksFasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). HbA1c will be measured by high-performance liquid chromatography (HPLC)
Effect of IGOB131 on homeostatic model assessment for insulin resistance (HOMA-IR)16 weeksFasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). HOMA-IR will be calculated using the formula: HOMA-IR = (fasting insulin \[µIU/mL\] × fasting glucose \[mg/dL\]) / 405
Effect of IGOB131 on TNF-α16 weeksFasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). TNF-α will be quantified using high-sensitivity ELISA kits according to the manufacturer's protocols.
Effect of IGOB131 on IL-616 weeksFasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). IL-6 will be quantified using high-sensitivity ELISA kits according to the manufacturer's protocols.
Effect of IGOB131 on body weight16 weeksBody weight will be measured using a calibrated digital scale with participants wearing light clothing and no shoes. Measurements will be performed in duplicate and averaged.
Effect of IGOB131 on BMI16 weeksBody mass index (BMI) will be calculated as body weight in kilograms divided by the square of height in metres (kg/m²). Height will be measured at baseline using a stadiometer, and body weight will be measured using a calibrated digital scale. Duplicate measurements will be averaged, as applicable. The outcome will be reported as BMI in kg/m².
Effect of IGOB131 on body fat percentage16 weeksBody fat percentage will be assessed using bioelectrical impedance analysis (BIA). Measurements will be performed in duplicate and averaged.
Effect of IGOB131 on waist circumference16 weeksWaist circumference will be measured at the midpoint between the lower rib margin and the iliac crest using a non-stretchable tape. Measurements will be performed in duplicate and averaged.

Contacts

CONTACTJulius E. Oben, PhD
juliusoben@hotmail.com+237651544949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 21, 2026