Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43866   clinical trials with a EudraCT protocol, of which   7287   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-002470-86
    Sponsor's Protocol Code Number:20190218
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2022-002470-86
    A.3Full title of the trial
    A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of AMG 133 in adults with obesity or overweight, with or without type 2 diabetes
    A.4.1Sponsor's protocol code number20190218
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05669599
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressRiesstr. 24
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80992
    B.5.3.4CountryGermany
    B.5.4Telephone number+488002643644
    B.5.6E-maileudemedinf@amgen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code AMG 133
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMaridebart Cafraglutide
    D.3.9.3Other descriptive nameAMG 133
    D.3.9.4EV Substance CodeSUB296450
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Overweight and Obesity
    E.1.1.1Medical condition in easily understood language
    Obesity
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.1
    E.1.2Level PT
    E.1.2Classification code 10033307
    E.1.2Term Overweight
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare and assess the dose-response of 3 selected doses of AMG 133 compared with placebo, on inducing and maintaining weight loss from baseline at week 52 in subjects with overweight or obesity without diabetes mellitus (cohort A) and in subjects with overweight or obesity with type 2 diabetes mellitus (cohort B).
    E.2.2Secondary objectives of the trial
    Key Secondary
    • To evaluate the effect of AMG 133 on achieving specific categories of body weight loss from baseline at week 52 in cohorts A and B
    • To evaluate the effect of AMG 133 on glucose metabolism in cohorts A and B
    • To characterize the pharmacokinetics (PK) properties of AMG 133 Secondary
    • To evaluate the effect of AMG 133 on waist circumference
    • To assess the treatment effect of dose-escalation regimens
    • To evaluate the effect of AMG 133 on systolic blood pressure (SBP)
    • To evaluate the effect of AMG 133 on diastolic blood pressure (DBP)
    • To evaluate the effect of AMG 133 on body composition in a subpopulation
    • To evaluate the effect of AMG 133 on a marker of inflammation
    • To evaluate the effect of AMG 133 on body mass index (BMI)
    • To evaluate the effect of AMG 133 on lipid parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are eligible to be included in the study only if all of the following criteria apply:
    - The subject has provided informed consent prior to initiation of any study-specific activities/procedures.
    - Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
    - Subject has a BMI ≥ 27 kg/m2 at screening.
    - Subject has had at least 1 unsuccessful attempt at weight loss by diet and exercise in the opinion of the investigator.
    - For subjects in cohort A only, the presence of at least 1 of the following weight-related complications: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease; or BMI ≥ 30 kg/m2.
    - For subjects in cohort A only, HbA1c < 6.5% (< 48 mmol/mol) at screening without a diagnosis of type 1 or 2 diabetes mellitus.
    - For subjects in cohort B only, HbA1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening.
    - For subjects in cohort B only, either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label.
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following criteria apply:
    Disease Related
    •Subjects with type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except type 2 diabetes mellitus (for cohort B only).
    •History of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy that requires acute treatment.
    •For the subjects in the DXA substudy only, body weight greater than the local DXA scanner capacity at screening.
    •Change in body weight > 5 kg within 90 days before screening per subject report or medical records.
    •For subjects in cohort B only, fasting glucose > 270 mg/dL (15.0 mmol/L) at screening.
    Other Medical Conditions
    •Any of the following within the last 6 months prior to screening:
    myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure; or currently have New York
    Health Association Class III or IV heart failure
    •Malignancy except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
    •Uncontrolled thyroid disease, defined as TSH > 6.0 mIU/L or < 0.4 mIU/L as measured by central laboratory at screening. Subjects who received treatment for hypothyroidism are permitted in the study, if their thyroid hormone replacement dose has been stable for at least 90 days and their TSH at screening is within the above range.
    •Obesity induced by other endocrine disorders (eg, Cushing syndrome).
    •History of severe or symptomatic gastroparesis.
    •A corrected QT interval (QTc) of > 450 msec in males or > 470 msec in females at screening as assessed by the investigator, or history of long QT syndrome.
    •Any of the following laboratory abnormalities at screening:
    i.An eGFR < 30 mL/min/1.73 m2 estimated according to chronic kidney disease epidemiology collaboration (CKD-EPI) equation.
    ii.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT):
    ≥ 2.5 times the upper limit of normal (ULN).
    iii.Other laboratory abnormalities that may affect the completion or evaluation of the study, as judged by the investigator.
    •Calcitonin ≥ 50 ng/L (pg/mL) at screening.
    •Lifetime history of acute or chronic pancreatitis, or elevation in serum lipase/amylase (> 2x ULN) at screening, or fasting serum triglyceride level of > 500 mg/dL at screening.
    •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
    •History of major depressive disorder within 2 years before randomization.
    •Lifetime history of other severe psychiatric disorders (eg, schizophrenia, bipolar disorder).
    •A PHQ-9 score of ≥ 15 at screening or day 1 before randomization.
    •Any lifetime history of a suicidal attempt.
    •Any suicidal behavior within 2 years before randomization.
    •Any suicidal ideation of type 4 or 5 on the C-SSRS at screening or day 1 before randomization.
    Prior/Concomitant Therapy
    •Treatment within 90 days before screening with any medication for obesity or that may cause significant weight change per the investigator's judgment, including but not limited to: phentermine, topiramate, zonisamide, lorcaserin, bupropion, naltrexone, orlistat, diethylpropion, exenatide, liraglutide, dulaglutide, semaglutide, tirzepatide, setmelanotide, pramlintide, leptin, or SGLT2 inhibitors (except for cohort B).
    •Previous or planned (during the study) obesity treatment with surgery or a weight loss device except for the following:
    iv.Liposuction and/or abdominoplasty that was performed > 1 year before screening
    v.Laparoscopic gastric band that was removed > 1 year before screening
    vi.Intragastric balloon that was removed > 1 year before screening
    vii.Duodenal-jejunal bypass sleeve that was removed > 1 year before screening
    •Treatment within 90 days before screening with medications that may cause significant weight gain, including systemic corticosteroids (except for a short course of treatment, ie, ≤ 10 days), tricyclic antidepressants, atypical antipsychotic, and mood stabilizers (eg, imipramine, amitryptiline, mirtazapin, paroxetine, phenelzine, clorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium).
    • Treatment within 90 days before screening with a central nervous system stimulant, eg, methylphenidate hydrochloride (Ritalin-SR®), amphetamine/dextroamphetamine mixed salts (Adderall XR®), and lisdexamfetamine (Vyvanse®), with the exception of caffeinated beverages.
    • Use within 90 days before screening of herbal supplements or overthe-counter medications taken for the purpose of weight loss.
    • Participation within 90 days before screening in an organized weight reduction program (eg, WeightWatchers®).
    See protocol for additional exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    • Percent change from baseline to week 52 in body weight
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 52
    E.5.2Secondary end point(s)
    Key Secondary:
    • Achieving ≥ 5% reduction in body weight from baseline at week 52 (yes/no)
    • Achieving ≥ 10% reduction in body weight from baseline at week 52 (yes/no)
    • Achieving ≥ 15% reduction in body weight from baseline at week 52 (yes/no)
    • Achieving ≥ 20% reduction in body weight from baseline at week 52 (yes/no)
    • Change from baseline to week 52 in hemoglobin A1c (HbA1c) (%, mmol/mol)
    • Change from baseline to week 52 in fasting serum insulin
    • Change from baseline to week 52 in fasting plasma glucose
    • Change from baseline to week 52 in Homeostasis Model Assessment for insulin resistance (HOMA2-IR)
    • Change from baseline to week 52 in Homeostasis Model Assessment for steady state beta cell function (HOMA2-%B)
    • PK parameters for AMG 133 including, but not limited to maximum observed plasma concentration (Cmax), and area under the concentration-time curve (AUC)
    Secondary
    • Change from baseline to week 52 in waist circumference
    • Change from baseline to week 52 in body weight
    • Change from baseline to week 52 in SBP
    • Change from baseline to week 52 in DBP
    • Change from baseline to week 52 in body composition (eg, fat mass, lean mass) using dual energy X ray absorptiometry (DXA) for a subset of subjects
    • Percent change from baseline to week 52 in high-sensitivity C-reactive protein (hs-CRP)
    • Change from baseline to week 52 in BMI
    • Percent change from baseline to week 52 in low density lipoprotein cholesterol (LDL-C)
    • Percent change from baseline to week 52 in total cholesterol
    • Percent change from baseline to week 52 in high density lipoprotein cholesterol (HDL-C)
    • Percent change from baseline to week 52 in non-HDL-C
    • Percent change from baseline to week 52 in very low-density lipoprotein cholesterol (VLDL-C)
    • Percent change from baseline to week 52 in triglycerides
    • Percent change from baseline to week 52 in free fatty acids (FFA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to week 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial18
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hong Kong
    Taiwan
    Australia
    Canada
    Japan
    Korea, Republic of
    United Kingdom
    United States
    Czechia
    Germany
    Hungary
    Poland
    Spain
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (ie, last subject last visit), including any additional parts in the study (eg, long-term follow-up, antibody testing), as applicable.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 560
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 570
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will continue to be treated by their attending physician with the appropriate medication available after leaving the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-08
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 30 07:46:20 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA