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CompletedPhase 2

Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes

A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes

Lead sponsor

KeyBioscience AG

Asset

KBP-042

Subcutaneous · Amylin analog

Listed sites

30

Recruiting sites

Enrollment

255

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥25HbA1c 7-10%

Primary endpoint

Blood HbA1c

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 IDNCT03230786
Org study IDKBP042/CD/003
Secondary ID2017-001061-24

Timeline

Milestones

Study first posted2017-07-26actual
Study start2017-08-23actual
Primary completion2018-07-09actual
Study completion2018-07-31actual
Last update posted2018-09-11actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female subjects, 18-75 years of age, both inclusive, at the time of the first screening visit. Women must be either using adequate, highly effective methods of contraception, be post-menopausal or be considered sterile due to tubal ligation or other surgical procedures at the time of randomization. Sexually active men with a female partner of childbearing potential must agree in the use of highly effective method of contraception by the female partner throughout the trial period.

2. Subjects with type 2 diabetes mellitus diagnosis whose HbA1c levels are ≥7.0% and ≤10.0% (53 mmol/mol to 86 mmol/mol, respectively) at screening.

3. Stable therapy (for at least 90 days prior to randomization) with metformin.

4. Body mass index (BMI) ≥ 25.0 kg/m², and ≤ 45.0 kg/m².

5. The subject is able to understand and comply with protocol requirements.

6. The subject is able and willing to give written informed consent.

Exclusion criteria

1. Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination.

2. Past or present significant co-morbidity (other than type 2 diabetes mellitus) including, but not limited to: Active liver disease (other than asymptomatic non-alcoholic fatty liver disease), significant renal disease (including creatinine clearance < 45 ml/min by the Modification of Diet in Renal Disease (MDRD) method, congestive heart failure (NYHA class III or IV), myocardial infarction within the past 12 months, unstable angina pectoris.

3. Prior treatment in clinical trials with dual amylin and calcitonin receptor agonists (DACRAs).

4. Currently receiving medical treatment for obesity.

5. History of bariatric surgery.

6. Current alcohol abuse.

7. Current medical non-metformin anti-diabetic therapy, including SGLT2-inhibitors, DPP4-inhibitors (dipeptidyl peptidase 4 inhibitors), GLP-1 (Glucagon-like peptide 1) analogues, insulin and sulfonylureas, for a period of 90 days prior to randomization.

8. Use of thiazolidinediones (glitazones) lasting for more than one month within 90 days of randomization.

9. Regular use of insulin or insulin analogues.

10. History or presence of sensitivity or allergy to the study drug or drugs, to their components, or drugs of these classes or a history of drug or other allergy that contraindicates participation.

11. History of sarcoma or other malignancy within the past five years, except adequately treated basal cell or squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.

12. Participation in a study trial with any investigational new drug (new chemical entity) within 90 days prior to the start of the study.

13. Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to randomization or during the treatment phase of the trial.

14. Breast-feeding women.

15. Known positive test results for hepatitis C antibodies, hepatitis B surface antigen, and HIV at screening.

16. ALT (alanine transaminase) or AST (aspartat transaminase) > 2.5 times the upper limit of normal at screening or other clinically significant liver function test abnormalities.

17. Clinically significant ECG abnormalities, as judged by the investigator.

Endpoints (6)

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

Glycemic / diabetes
4
Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change from baseline in body weight at 12 weeks versus placebo.

Time frame:At 12 weeks

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change from baseline in blood HbA1c at 12 weeks versus placebo.

Time frame:At 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting serum glucose at 12 weeks versus placebo

Time frame:At 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting serum insulin at 12 weeks versus placebo

Time frame:At 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo

Time frame:At 12 weeks

threshold achievement, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline in fasting serum glucagon at 12 weeks versus placebo

Time frame:At 12 weeks

change from baseline, improvement

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.