Obesity & OverweightPhase 2NCT07884058
IGOB131 As A GLP-1 Modulator For Metabolic Disorders In Adults With Obesity
A Phase 2 study testing IGOB131 and Dextrin in people with Obesity & Overweight, run by University of Yaounde 1.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- IGOB131 and Dextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized, Double-Blind, Placebo-controlled Trial Of IGOB131 As A GLP-1 Modulator For Metabolic Disorders In Adults With Obesity
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
Read the 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.
- Conditions
- Obesity & Overweight
- Being tested
- IGOB131, Dextrin
- Keywords
- GLP-1, DPP-4, obesity, insulin resistance, inflammation, nutraceutical
- Medical subject headings
- Obesity, Overweight, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGOB131Drug
IGOB-131 is an encapsulated, standardized botanical extract derived from Irvingia gabonensis.
DextrinDrug
Placebo capsules containing 400 mg of dextrin, looking identical to IGOB131 capsules
| Study group | Role | What they receive |
|---|---|---|
| IGOB131 Group | Experimental | 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. Receives: Drug: IGOB131 |
| Placebo Group | Active comparator | 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. Receives: Drug: Dextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 16 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yaounde 1
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Julius Oben, University of Yaounde 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884058
- Sponsor's protocol ID
- GLP1-IGOB
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Patel S, Niazi SK. Emerging Frontiers in GLP-1 Therapeutics: A Comprehensive Evidence Base (2025). Pharmaceutics. 2025 Aug 9;17(8):1036. doi: 10.3390/pharmaceutics17081036.
PubMed 40871057Ahmad N, Alruwayyes A, Alarjani A, Tawhari A, Aldosri A, Alahmari A, Balaha M. GLP-1 receptor agonists for weight loss: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2026 Mar 13;105(11):e47994. doi: 10.1097/MD.0000000000047994.
PubMed 41824845Hotamisligil GS. Inflammation, metaflammation and immunometabolic disorders. Nature. 2017 Feb 8;542(7640):177-185. doi: 10.1038/nature21363.
PubMed 28179656Oben JE, Ngondi JL, Blum K. Inhibition of Irvingia gabonensis seed extract (OB131) on adipogenesis as mediated via down regulation of the PPARgamma and leptin genes and up-regulation of the adiponectin gene. Lipids Health Dis. 2008 Nov 13;7:44. doi: 10.1186/1476-511X-7-44.
PubMed 19014517Ngondi JL, Etoundi BC, Nyangono CB, Mbofung CM, Oben JE. IGOB131, a novel seed extract of the West African plant Irvingia gabonensis, significantly reduces body weight and improves metabolic parameters in overweight humans in a randomized double-blind placebo controlled investigation. Lipids Health Dis. 2009 Mar 2;8:7. doi: 10.1186/1476-511X-8-7.
PubMed 19254366Manach C, Williamson G, Morand C, Scalbert A, Remesy C. Bioavailability and bioefficacy of polyphenols in humans. I. Review of 97 bioavailability studies. Am J Clin Nutr. 2005 Jan;81(1 Suppl):230S-242S. doi: 10.1093/ajcn/81.1.230S.
PubMed 15640486Green BD, Gault VA, O'Harte FP, Flatt PR. A comparison of the cellular and biological properties of DPP-IV-resistant N-glucitol analogues of glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide. Diabetes Obes Metab. 2005 Sep;7(5):595-604. doi: 10.1111/j.1463-1326.2004.00455.x.
PubMed 16050953Gasoyan H, Pfoh ER, Schulte R, Le P, Butsch WS, Rothberg MB. One-Year Weight Reduction With Semaglutide or Liraglutide in Clinical Practice. JAMA Netw Open. 2024 Sep 3;7(9):e2433326. doi: 10.1001/jamanetworkopen.2024.33326.
PubMed 39269703Deacon CF. Dipeptidyl peptidase 4 inhibitors in the treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2020 Nov;16(11):642-653. doi: 10.1038/s41574-020-0399-8. Epub 2020 Sep 14.
PubMed 32929230Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409-39. doi: 10.1152/physrev.00034.2006.
PubMed 17928588Drucker DJ. Mechanisms of Action and Therapeutic Application of Glucagon-like Peptide-1. Cell Metab. 2018 Apr 3;27(4):740-756. doi: 10.1016/j.cmet.2018.03.001.
PubMed 29617641Franz MJ, VanWormer JJ, Crain AL, Boucher JL, Histon T, Caplan W, Bowman JD, Pronk NP. Weight-loss outcomes: a systematic review and meta-analysis of weight-loss clinical trials with a minimum 1-year follow-up. J Am Diet Assoc. 2007 Oct;107(10):1755-67. doi: 10.1016/j.jada.2007.07.017.
PubMed 17904936Hruby A, Hu FB. The Epidemiology of Obesity: A Big Picture. Pharmacoeconomics. 2015 Jul;33(7):673-89. doi: 10.1007/s40273-014-0243-x.
PubMed 25471927