GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 1

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

A Double-blind, Placebo-controlled, Randomised, Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KBP-089 in Patients With Type II Diabetes

Lead sponsor

KeyBioscience AG

Asset

KBP-089

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 7-9.5%

Primary endpoints

•Treatment Emergent Adverse Events (TEAEs)•Vital sign - Blood Pressure•Vital sign - Pulse

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03907202

Org study IDKBP089/CD/002

Timeline

Milestones

Study start2018-04-17actual

Study first posted2019-04-08actual

Primary completion2019-12-03actual

Study completion2019-12-03actual

Last update posted2020-09-03actual

Assets

Investigational agents

KBP-089

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the patient).

•Male or female patient with T2DM.

•Age between 18 and 64 years, both inclusive.

•Body Mass Index (BMI) >= 25.0 kg/m^2.

•HbA1c >= 7 and <=9.5%.

•Stable therapy with metformin ± treatment with a second oral anti-diabetes drug (OAD) belonging to the class of dipeptidyl-peptidase 4 (DPP-4) inhibitors or sulfonylureas for at least 2 months prior to inclusion into the trial or not treated with glucose-lowering medications. Patients who are receiving stable treatment with a second OAD will be asked to discontinue the DPP-4 inhibitor or a sulfonylurea for at least 14 days prior the Initial Inpatient Dosing Visit.

•Considered generally healthy (apart from T2DM) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator.

Exclusion criteria

•Known or suspected hypersensitivity or allergy to paracetamol or related products.

•Prior treatment with a dual amylin and calcitonin receptor agonist (DACRA) or salmon calcitonin.

•Receipt of any medicinal product in clinical development within 30 days or 5 half-lives of the medicinal product (whichever is longer) before randomisation in this trial.

•History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

•Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.

•Medically unable or unwilling to discontinue current anti-diabetic therapy with DPP-4 inhibitor or sulfonylurea for at least 14 days prior to admission to the research facility (Day -2) and remain off medication until the follow-up visit. Patients taking metformin therapy at entry will continue their metformin at the usual individual dose throughout the trial.

•Have had a significant change in weight, defined as a gain or loss of at least 5% body weight in the 3 months prior to screening.

•A positive result in the alcohol and/or urine drug screen at the screening visit.

•Positive to the screening test for Hepatitis Bs antigen (HBsAg) or Hepatitis C antibodies and/or a positive result to the test for human immunodeficiency virus (HIV)-1/2 antibodies or HIV-1 antigen.

•Have had a blood transfusion or severe blood loss within the past 6 months or have known hemoglobinopathy, hemolytic anemia, sickle cell anemia, or have a hemoglobin value <11 g/dL (males) or <10 g/dL (females), or any other condition known to interfere with HbA1c methodology.

•Blood donation or blood loss of more than 500 mL within the last 3 months or any blood donation within the last month prior to screening.

•Females of childbearing potential.

•Males with pregnant partners.

Endpoints (24)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Body weight.

Time frame:Day -1 to day 28

descriptive

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Fasting and postprandial glucose concentration.

Time frame:Day -1 to day 28

concentration, descriptive

Secondary/protocol endpoint

Fasting and postprandial insulin concentration.

Time frame:Day -1 to day 28

concentration, descriptive

Secondary/protocol endpoint

Fasting and postprandial C-peptide concentration.

Time frame:Day -1 to day 28

concentration, descriptive

Secondary/protocol endpoint

N-(1-deoxy)-fructosyl-haemoglobin (HbA1c).

Time frame:Day -1 to day 28

descriptive

Cardiometabolic biomarkers

3 endpoints

Primary/protocol endpoint

Vital sign - Blood Pressure.

Time frame:Day -1 to day 28

descriptive

Primary/protocol endpoint

Vital sign - Pulse (beats per min).

Time frame:Day -1 to day 28

descriptive

Primary/protocol endpoint

Safety laboratory parameter - lipids.

Time frame:Day -1 to day 28

descriptive

Safety / tolerability / PK

15 endpoints

Primary/protocol endpoint

Treatment Emergent Adverse Events (TEAEs).

Time frame:Day -1 to day 28

descriptive

Primary/protocol endpoint

Vital sign - Body Temperature.

Time frame:Day -1 to day 28

descriptive

Primary/protocol endpoint

Vital sign - Respiratory frequency.

Time frame:Day -1 to day 28

descriptive

Primary/protocol endpoint

Electrocardiogram (ECG) - PQ interval.

Time frame:Day -1 to day 28

descriptive

Primary/protocol endpoint

Electrocardiogram (ECG) - QRS complex.

Time frame:Day -1 to day 28

descriptive

Primary/protocol endpoint

Electrocardiogram (ECG) - QT interval.

Time frame:Day -1 to day 28

descriptive

Primary/protocol endpoint

Safety laboratory parameter - haematology.

Time frame:Day -1 to day 28

descriptive

Primary/protocol endpoint

Safety laboratory parameter - coagulation.

Time frame:Day -1 to day 28

descriptive

Primary/protocol endpoint

Safety laboratory parameter - urinalysis.

Time frame:Day -1 to day 28

descriptive

Secondary/protocol endpoint

Pharmacokinetic Evaluation - KBP-089 Area Under Curve.

Time frame:Day -1 to day 28

descriptive

Secondary/protocol endpoint

Pharmacokinetic Evaluation - KBP-089 Cmax.

Time frame:Day -1 to day 28

concentration, descriptive

Secondary/protocol endpoint

Gastric emptying - Paracetamol Cmax.

Time frame:Day -1 to day 28

concentration, descriptive

Secondary/protocol endpoint

Gastric emptying - Paracetamol Tmax.

Time frame:Day -1 to day 28

concentration, descriptive

Secondary/protocol endpoint

Gastric emptying - Paracetamol Area Under Curve (AUC).

Time frame:Day -1 to day 28

concentration, descriptive

Secondary/protocol endpoint

Fridericia's corrected QT interval (QTcF).

Time frame:Day 1 to day 27

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Fasting and postprandial glucagon concentration.

Time frame:Day -1 to day 28

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.