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HP-211 dose-ranging safety and proof-of-concept for people with type 2 diabetes

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

PHASE2 · Housey Healthcare ULC · NCT07546929

This trial will test different doses of HP-211 to see if the medicine is safe and helps lower blood sugar in adults with early type 2 diabetes who are on metformin or diet and exercise.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorHousey Healthcare ULC (industry)
Locations25 sites (Canoga Park, California and 24 other locations)
Trial IDNCT07546929 on ClinicalTrials.gov

What this trial studies

This Phase 2, dose-ranging study gives participants either HP-211 or placebo at specified dose levels and follows them for safety and measures of blood glucose control. Eligible participants have relatively recent type 2 diabetes (between 3 months and 5 years), an HbA1c between 6.5% and 10%, and are on a stable regimen of metformin or diet/exercise. Safety monitoring will include vital signs and adverse event reporting, and efficacy signals will be assessed using lab measures such as HbA1c and other glucose-related tests. The study is conducted at outpatient clinical research sites in California and Florida.

Who should consider this trial

Good fit: Ideal candidates are adults with type 2 diabetes diagnosed between 3 months and 5 years ago who have an HbA1c >6.5% and ≤10% and have been on a stable maximum dose of metformin or on diet and exercise alone for at least 3 months.

Not a fit: People with type 1 diabetes, those with diabetic complications, those currently using or recently exposed to other oral or injectable diabetes drugs (other than metformin), or with uncontrolled high blood pressure are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If successful, HP-211 could become a new oral option that safely helps lower blood sugar in people with early type 2 diabetes.

How similar studies have performed: Other early-phase trials of novel oral agents targeting insulin signaling have shown mixed but sometimes promising signals, while HP-211 itself represents a relatively new agent with limited prior public clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.

Where this trial is running

Canoga Park, California and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Type 2 Diabetes

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.