A Phase 2 interventional study of IGOB131 and Dextrin in Obesity & Overweight, sponsored by University of Yaounde 1. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University of Yaounde 1 · Phase 2, Interventional, and Treatment
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
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 80 is close to the median of 77 across 5,084 interventional studies indexed under Obesity.
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Exclusion Criteria:
40 participants aged 18-65 with a BMI between 25 - 34 kg/m 2 randomly assigned to the IGOB131 group will be administered 300mg IGOB131 capsule daily for 16 weeks. Participants will be instructed to maintain their usual lifestyle and dietary habits and to report any delays in taking the capsules.
Drug: IGOB131
40 participants aged 18-65 with a BMI between 25 - 34 kg/m 2 randomly assigned to the placebo group will be administered a 400 mg dextrin capsule daily for 16 weeks. Participants will be instructed to maintain their usual lifestyle and dietary habits and to report any delays in taking the capsules.
Drug: Dextrin
IGOB-131 is an encapsulated, standardized botanical extract derived from Irvingia gabonensis.
Placebo capsules containing 400 mg of dextrin, looking identical to IGOB131 capsules
Effect of IGOB131 on postprandial GLP-1 response (0-180 minutes)
Postprandial 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.
Time frame: 16 weeks
Effect of IGOB131 on fasting plasma GLP-1 concentrations
Blood 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).
Time frame: 16 weeks
Effect of IGOB131 on DPP-4 enzymatic activity
Fasting 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.
Time frame: 16 weeks
Effect of IGOB131 on fasting blood glucose
Fasting 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.
Time frame: 16 weeks
Effect of IGOB131 on fasting insulin
Fasting 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.
Time frame: 16 weeks
Effect of IGOB131 on glycated hemoglobin (HbA1c)
Fasting 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)
Time frame: 16 weeks
Effect of IGOB131 on homeostatic model assessment for insulin resistance (HOMA-IR)
Fasting 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
Time frame: 16 weeks
Effect of IGOB131 on TNF-α
Fasting 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.
Time frame: 16 weeks
Effect of IGOB131 on IL-6
Fasting 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.
Time frame: 16 weeks
Effect of IGOB131 on body weight
Body 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.
Time frame: 16 weeks
Effect of IGOB131 on BMI
Body 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.
Time frame: 16 weeks
Effect of IGOB131 on body fat percentage
Body fat percentage will be assessed using bioelectrical impedance analysis (BIA). Measurements will be performed in duplicate and averaged.
Time frame: 16 weeks
Effect of IGOB131 on waist circumference
Waist 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.
Time frame: 16 weeks
No study locations are listed for this record.
Plan to share: Yes — Metabolic parameters (Blood sugar, Blood lipid), Anthroprmetric measures (height, weight, BMI and body fat percentage) DPP-4 and GLP-1 levels data collected through out the study
Start is estimated for Dec 2026; primary completion for Oct 2027, 10 months later.
Of 91 non-industry phase 2 interventional studies under Obesity, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 63. This study's planned 10 months is below that.
Counting every sponsor, half of 232 studies reached it within 15 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Yaounde 1