A randomized patient-and-physician blinded, placebo- controlled, 24-week study to assess the safety, tolerability and efficacy of LMB763 in patients with diabetic nephropathy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

LBCTR

Registry ID

LBCTR2019020193

Enrollment

Registered

2022-03-23

Start date

2019-05-15

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Diabetic Nephropathy Nephropathy

Interventions

•Drug: LMB763 LMB763 capsule •Other: Placebo Placebo capsule

ICF, IMP, Lab tests and ECG , diary completion

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: •Male/female patients, 18-75 years •Written informed consent •Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to screening •Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) =300 mg/g Cr while receiving a maximally tolerated (optimal) dose of angiotensin converting enzyme inhibitor or angiotensin receptor blocker

Exclusion criteria

Exclusion criteria: Exclusion Criteria: •History of type 1 diabetes mellitus •Severe renal impairment manifesting as serum creatinine eGFR < 30 mL/min/1.73 m^2 at screening •Pregnant or nursing (lactating) women •Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping study medication •Uncontrolled diabetes mellitus •History or current diagnosis of ECG abnormalities •History of kidney disease other than diabetic nephropathy

Design outcomes

Primary

Measure	Time frame
Name: To compare the effect of LMB763 to;Timepoints: at serial timepoints as discrived in protoocl ;Measure: serial timepoints as per protocol;Name: •Adverse event profile and safety endpoints of LMB763 ;Timepoints: 197 days;Measure: 197 days	—

Secondary

Measure	Time frame
Name: To determine the effect of LMB763 on;Timepoints: Estimated glomerular filtration rate (eGFR), as;Measure: eGFR	—

Countries

Argentina, Czech Republic, Germany, Jordan, Lebanon, Turkey, United States of America

Contacts

Public ContactHilal Abu Zeinab

Hammoud Hospital

hilal@abouzeinab.com9613811611

Outcome results

None listed

Source: LBCTR (via WHO ICTRP) · Data processed: Feb 7, 2026