Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes (SYMPHONY-1)

HighTide Therapeutics

Status and phase: Completed; Phase 3

Conditions: T2DM (Type 2 Diabetes Mellitus)

Treatments: Drug: HTD1801; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06350890

HTD1801.PCT105

Details and patient eligibility

About

The goal of this clinical study is to evaluate the efficacy and safety of Berberine Ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes, inadequately controlled with diet and exercise alone.

Full description

This Phase 3 randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of HTD1801 in two phases, a 24-week double-blind phase followed by a 28-week open-label extension. To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 2:1 to receive HTD1801 1000 mg twice daily (BID) or placebo for 24 weeks.

Patients who complete the double-blind treatment period will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for an additional 28 weeks.

Enrollment: 408 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Have been diagnosed with Type 2 diabetes mellitus
• Have followed dietary and exercise interventions for at least 8 weeks prior to screening
• If used any glucose-lowering drugs within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening
• Have HbA1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization)
• Have fasting plasma glucose ≤13.9 mmol/L (screening and pre-randomization)
• Have a body mass index ≥19.0 kg/m^2 to ≤35.0 kg/m^2

Key Exclusion Criteria:

• Have type 1 diabetes
• Have had any acute diabetic complications within 12 months prior to screening
• Have had any Grade 3 hypoglycemic event within 12 months prior to screening
• Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot
• Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 12 weeks prior to screening
• Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
• Have used any hypoglycemic drug during the 4-week run-in period prior to randomization
• Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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408 participants in 2 patient groups, including a placebo group

HTD1801

Experimental group

Description:

Administered orally twice daily (BID)

Treatment:

Drug: HTD1801

Placebo

Placebo Comparator group

Description:

Administered orally BID

Treatment:

Drug: Placebo