HP-211 Study for Type 2 Diabetes

This study is looking into HP-211, an investigational botanical extract, for people with Type 2 Diabetes. Researchers want to see how safe HP-211 is and if different doses can help improve blood sugar control. You might be able to join if you are 18 or older, have had Type 2 Diabetes for 3 months to 5 years, and your HbA1c (a measure of average blood sugar over 2-3 months) is between 6.5% and 10%. You also need to be on a stable dose of metformin. The main goal is to see how much your HbA1c changes after 12 weeks of treatment with HP-211 compared to a placebo (an inactive substance). The study is currently unclear about its recruitment status and plans to enroll 300 participants.

Study design
This is an interventional study, meaning participants will receive either HP-211 or a placebo. It aims to enroll 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured after 12 weeks of treatment.

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NCT07546929

HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes

Recruiting
PHASE2Ages 18+InterventionalTreatment
Housey Healthcare ULC
~300 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:HP-211Placebo

At a glance

Recruiting sites
25 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured over After 12 weeks of treatment.
Type 2 Diabetes
25 sites across 12 states
Texas7
Florida6
Ohio2
Virginia2
California1
Georgia1
Kansas1
Louisiana1

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Eligibility criteria

Inclusion

Have type 2 diabetes for greater than 3 months and no longer than 5 years by history prior to entering the trial, based upon ADA disease diagnostic criteria.
Have an HbA1c \> 6.5% and ≤ 10% as determined by the central lab at Visit 1 (Screening).
Have been on a stable maximum dose of metformin for at least 3 months prior to entering the study or have been on stable therapy of diet and exercise only for at least 3 months. Stable treatment is defined as no change in treatment or dose in the last 3 months.

Exclusion

Have known type 1 diabetes.
Diabetic complications
Have taken any oral (other than metformin) or injectable treatment (insulin or GLP-1 RA classes or other) for type 2 diabetes currently or for greater than a 4 week duration previously. Previous treatment must have been stopped at least 3 months prior to screening
Systolic blood pressure greater than 150 mmHg or a diastolic blood pressure greater than 100 mmHg at Visit 1 on average after three supine measurements, or a known history of renal artery stenosis.
At baseline, the QT interval corrected by Fridericia (QTcF) ECG findings (\>450 msec for males and \>470 msec for females), left bundle branch block, or cardiac arrhythmia requiring medical or surgical treatment within 6 months prior to Visit 1 on the ECG.
  • Change from Baseline in Hemoglobin A1c (HbA1c)After 12 weeks of treatment.

    Least squares mean change from baseline in HbA1c at Week 12, analyzed using a mixed model for repeated measures (MMRM).