A Study to Determine the Safety and Tolerability of a Range of Doses of PeptiControl in Pre-diabetic Individuals
NCT06440213, Not applicable, Completed, Nuritas Ltd
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study to Determine the Safety and Tolerability of a Range of Doses of PeptiControl in Pre-diabetic Individuals | ClinicalTrials.gov |
| NCT number | NCT06440213 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 132 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Nuritas Ltd | ClinicalTrials.gov |
| Conditions | Pre Diabetes, Overweight | ClinicalTrials.gov |
| Interventions | PeptiControl™ (Low - Dose 435 mg/day), PeptiControl™ (Mid - Dose 870 mg/day), PeptiControl™ (High - Dose 2610 mg/day), Placebo Microcrystalline Cellulose | ClinicalTrials.gov |
| First posted | 2024-06-03 | ClinicalTrials.gov |
| Last updated | 2025-03-13 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | To investigate the safety and tolerability of a range of doses of PeptiControl™ as assessed by occurrence of hypoglycemic episodes evaluated by time below target range (70 - 180 mg/dL) during Continuous Glucose Monitoring (CGM) | Day 0 to Day 10 | The hypoglycemic events will be monitored and recorded from the day of IP initiation (Day 0) until the end of study (Day 10). The tolerability of different doses of PeptiControl™ will be assessed on the basis of the hypoglycemic episodes evaluated by time below target range (70 - 180 mg/dL) during CGM throughout the study in each arm. | ClinicalTrials.gov |
| Secondary | To explore the safety of a range of doses of PeptiControl™ as assessed by a safety blood panel comparing baseline and post dose parameters. | Day 0 and Day 6 | Blood samples will be taken from participants pre and post consumption of PeptiControl and analysed in a safety blood panel assessing liver, kidney and lipid markers for the identification of any changes from baseline. | ClinicalTrials.gov |
| Secondary | To assess the efficacy of range of doses of PeptiControl™ on blood glucose concentrations when given 30 minutes prior to Oral Glucose Tolerance Test (OGTT) compared to placebo | Day 0 | Thirty minutes post IP consumption, participants will consume a glucose solution (comprising of 75g glucose in approximately 250 ml water). Blood samples will then be collected at 15, 30, 60, 90, 120 and 180 mins for the assessment of blood glucose concentrations | ClinicalTrials.gov |
| Secondary | To assess the efficacy of range of doses of PeptiControl™ on Glucose metabolism as assessed by incremental Area Under Curve (iAUC) | Day 0 | The glucose iAUC will be derived from the OGTT. This assessment will be conducted at 0, 15, 30, 60, 90, 120 and 180 mins after glucose solution consumption | ClinicalTrials.gov |
| Secondary | To assess the efficacy of range of doses of PeptiControl™ on Pancreatic efficiency | Day 0 and Day 6 | Pancreatic efficiency will be evaluated by fasting serum insulin levels in blood Fasting insulin: Normal range - 2.6-24.9 μU/mL (17.8-173 pmol/L) | ClinicalTrials.gov |
| Secondary | To assess the efficacy of range of doses of PeptiControl™ Time in range via CGM (Continuous Glucose Monitoring). | Starting from day -2 and worn continuously until day 10 with readings taken at day -2, day 0, day 6, day 10 | Continuous glucose monitoring device automatically calculates the time in the blood glucose target range (70 - 180 mg/dl) as well as above and below the target range | ClinicalTrials.gov |
| Secondary | To assess the efficacy of range of doses of PeptiControl™ on Insulin sensitivity as assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). | Day 0 and Day 6 | Insulin sensitivity will be assessed by HOMA-IR. The HOMA - IR score will be calculated using the formula: fasting insulin (mU/L) x fasting glucose (mmol/L)/22.5. Fasting insulin: Normal range - 2.6-24.9 μU/mL (17.8-173 pmol/L) Fasting Glucose: Normal range - 4.11-6.05 mmol/L(74-109 mg/dL) | ClinicalTrials.gov |
| Secondary | To assess the efficacy of range of doses of PeptiControl™ on Working memory as assessed by Paired Associate Learning test | Day 0, Day 6, and Day 10 | Working memory will be assessed using the Validated Paired Associate Learning test by Creyos. | ClinicalTrials.gov |
| Secondary | To assess the efficacy of range of doses of PeptiControl™ on Selective attention as assessed by Stroop test. | Day 0, Day 6, and Day 10 | Selective attention will be assessed using the Double Trouble/Stroop test by Creyos | ClinicalTrials.gov |
| Secondary | To assess the efficacy of range of doses of PeptiControl™ on Hunger, satiety and fullness as assessed by the Visual Analog Scale (VAS) | Day 0, Day 6, and Day 10 | The VAS will be 100 mm in length with words anchored at each end expressing the most positive and the most negative rating. It will assess five components: hunger, satiety, fullness, prospective food consumption and desire to eat. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Paired Associate Learning | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)