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A Clinical Study to Evaluate the Safety, Tolerability, PK, PD, and Efficacy of KBP-089 in Patients With T2DM

NCT03907202 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-09-03

No results posted yet for this study

Summary

KeyBioscience is developing KBP-089, a dual activator of both the amylin and calcitonin receptors, for the treatment of type II diabetes mellitus, using a subcutaneous injectable mode of administration.

This is a double-blind, placebo-controlled, randomised, multiple-ascending dose phase I trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of KBP-089 in patients with type 2 diabetes, who are on stable therapy with metformin.

Subjects will receive daily subcutaneous injections in the abdomen over a period of 28 days. The planned maximum doses of KBP-089 to be investigated in the trial are 20 µg in cohort 1, 60 µg in cohort 2, and 150 µg in cohort 3. For cohort 1, the dose is planned to be escalated every 7 ±1 days, and for cohort 2 and cohort 3, every 3 days. Doses may be modified according to individual tolerability, but the dose regimen will not exceed 28 days.

The IMP is administered by daily subcutaneous injections taken in the morning before breakfast.

The trial is performed in Germany and at least 36 patients will be enrolled in the trial. The trial will be randomised 1:1:1 between maximum doses of KBP-089 of 20 µg, 60 µg, 150 µg and placebo. Within each of the three cohorts, 12 patients will be randomised 3:1 to KBP-089 and placebo.

Conditions

  • Type II Diabetes Mellitus

Interventions

DRUG

Daily injection of KBP/placebo for up to 28 days

Daily sub-cutaneous injection of KBP-089/Placebo into a lifted skin fold of the abdominal wall.The injection will be administered in the morning before breakfast.

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Nordic Bioscience A/S

    collaborator INDUSTRY

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • KeyBioscience AG

    lead INDUSTRY

Principal Investigators

  • Tim Heise, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2019-12-03
Completion
2019-12-03
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03907202 on ClinicalTrials.gov