Study of the Gut Hormone Analogue Y14 in Adult Subjects | NCT03673111 | Trialant
NCT03673111
Sponsor
Imperial College London
Status
Completed
Last Update Posted
Mar 18, 2025Actual
Enrollment
77Actual
Phase
Phase 1
Conditions
Diabetes Mellitus
Obesity
Interventions
Y14
Placebo
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03673111
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ICIM/2016/Y14/01
Secondary IDs
ID
Type
Description
Link
2017-000380-33
EudraCT Number
Brief Title
Study of the Gut Hormone Analogue Y14 in Adult Subjects
Official Title
A Randomised, Placebo Controlled First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Y14 in Adult Subjects
Acronym
Not provided
Organization
Imperial College LondonOTHER
Status Module
Record Verification Date
Mar 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 10, 2017Actual
Primary Completion Date
Feb 13, 2019Actual
Completion Date
Feb 13, 2019Actual
First Submitted Date
May 23, 2018
First Submission Date that Met QC Criteria
Sep 13, 2018
First Posted Date
Sep 17, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Mar 4, 2021
Results First Submitted that Met QC Criteria
Mar 10, 2025
Results First Posted Date
Mar 18, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 10, 2025
Last Update Posted Date
Mar 18, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Imperial College LondonOTHER
Collaborators
Name
Class
Medical Research Council
OTHER_GOV
Covance
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A randomised, placebo controlled Phase I study to investigate investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Y14 in adult subjects.
Detailed Description
Objectives:
Primary Objective
To investigate the safety and tolerability of single doses of Y14 in overweight/obese but otherwise healthy male subjects.
To investigate the safety and tolerability of multiple doses of Y14 in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.
Secondary Objectives
To assess the pharmacokinetic (PK) profile of single doses of Y14 in overweight/obese but otherwise healthy male subjects.
To assess the PK profile of multiple ascending doses of Y14 in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.
Exploratory Objective
To investigate the effects of multiple doses of Y14 on food consumption, body weight and glucose tolerance in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.
Conditions Module
Conditions
Diabetes Mellitus
Obesity
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
77Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1.0 mg Y14 (A1)
Experimental
Y14 single dose, subcutaneous
Drug: Y14
2.0 mg Y14 (A1)
Experimental
Y14 single dose, subcutaneous
Drug: Y14
6.0 mg Y14 (A1)
Experimental
Y14 single dose, subcutaneous
Drug: Y14
9.0 mg Y14 (A2) with varied formulation
Experimental
Y14 single dose, subcutaneous
Drug: Y14
18.0 mg Y14 (A5) with varied formulation
Experimental
Y14 single dose, subcutaneous
Drug: Y14
36.0 mg Y14 (A6) with varied formulation
Experimental
Y14 single dose, subcutaneous
Drug: Y14
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Y14
Drug
Gut hormone analogue
1.0 mg Y14 (A1)
12-36 mg (B3)
18 mg Y14 (A7) with varied formulation
18.0 mg Y14 (A5) with varied formulation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Safety and Tolerability)
As assessed by reporting of adverse events, vital signs, physical examination, clinical laboratory safety assessments, and ECG parameters.
Possibly or definitely related to study drug
Up to 73 days after dosing
Secondary Outcomes
Measure
Description
Time Frame
Cmax
The maximum observed concentration
For Part A, Cohorts A3 to A9 - up to 840 hour post dose. For Part B - up to day 70 post 1st dose
AUC 0-72h
The area under the concentration versus time curve from time zero to 72 h postdose, calculated by the mixed linear/log trapezoidal rule
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adult males aged 18 to 65 years inclusive with BMI between 25.0 and 38.0 kg/m2 inclusive;
(PART B only) Subjects who have normal glucose tolerance, Type 2 diabetes, impaired glucose tolerance or impaired fasting glucose according to WHO 2006 and 2011 criteria;
Subjects who are otherwise healthy enough to participate, as determined by pre-study medical history, physical examination and 12-lead ECG;
Subjects whose clinical laboratory test results are either within the normal range or if outside this range the abnormalities are judged to be not clinically relevant and are acceptable to the Investigator;
Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;
Subjects who are negative for drugs of abuse and alcohol tests at screening and admissions;
Subjects who are non-smokers for at least 3 months preceding screening;
Subjects who agree to use medically acceptable methods of contraception for at least 3 months after study drug administration;
Subjects who agree not to donate sperm for at least 3 months after study drug administration;
Subjects who are able and willing to give written informed consent.
Exclusion Criteria:
Subjects who do not conform to the above inclusion criteria;
Subjects who have a clinically relevant history or presence of gastrointestinal (especially associated with vomiting), respiratory, renal, hepatic, haematological, lymphatic, neurological (especially if associated with balance disorders or vomiting e.g. migraine or labyrinthitis), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders;
Subjects who have a clinically relevant surgical history;
Subjects who are currently taking any of the following classes of diabetes medications: thiazolidinediones, dipeptidyl peptidase IV inhibitors ('gliptins'), GLP-1 analogues, and insulin;
Subjects who have a history of relevant and severe atopy e.g. asthma, angioedema requiring emergency treatment, severe hayfever requiring regular treatment (i.e. taking antihistamines and/or glucocorticoids more regularly than 3 times a week), severe eczema requiring regular treatment (i.e. taking antihistamines and/or glucocorticoids more regularly than 3 times a week);
Subjects who have a history of relevant drug hypersensitivity;
Subjects who have a history of alcohol abuse or alcohol dependence according to DSMIV criteria within the last 2 years;
Subjects who have a history of drug or substance abuse according to DSM-IV criteria within the last 2 years;
Subjects who have a history of clinically significant migraine as judged by the Investigator. Subjects can be included if they have not had a migraine for the last 3 years;
Subjects with a history of pancreatitis or pancreatic cancer;
Subjects who consume more than 21 units of alcohol a week (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer);
Subjects who have a significant infection or known inflammatory process on screening;
Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn);
Subjects who have an acute infection such as influenza at the time of screening or admission;
Subjects who have used prescription drugs within 2 weeks of first dosing. For Part B, patients are allowed to be treated for their diabetes with monotherapy with a sulphonylurea, metformin, or a SGLT-2 inhibitor, dual therapy with any two of the following drug types: a sulphonylurea, metformin, and/or a SGLT-2 inhibitor; triple therapy with a sulphonylurea, metformin, and a SGLT-2 inhibitor. In addition patients in Part B are allowed to take hypolipidaemic and/or antihypertensive treatments, provided that the doses have not been altered within the 4 weeks prior to entering the study. Other medications may be allowed if the Investigator and Sponsor both agree that they will not affect the outcome of the study or the safety of the subject.
Subjects who have used over the counter medication excluding routine vitamins and paracetamol but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as not clinically relevant by the Principal Investigator and Sponsor;
Subjects who have donated blood within 3 months prior to screening; Subjects who have donated plasma within the 7 days prior to screening; Subjects who have donated platelets within the 6 weeks prior to screening
Subjects who have used any investigational drug in any clinical trial within 3 months of their first admission date;
Subjects who have received the last dose of investigational drug greater than 3 months ago but who are on extended follow-up;
Subjects who have previously received Y14;
Subjects who are vegans, vegetarian or have any dietary restriction (unless agreed as not clinically relevant by the PI and Sponsors);
Subjects who cannot communicate reliably with the Investigator;
Subjects who are unlikely to co-operate with the requirements of the study;
History or evidence of abnormal eating behaviour, as observed through the Dutch Eating Behaviour (DEBQ) and SCOFF questionnaires at screening.
Accepts Healthy Volunteers
Yes
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Stephen Bloom, FMedSci, FRS
Sponsor Chief Investigator, Imperial College London
Tan TM, Minnion J, Khoo B, Ball LJ, Malviya R, Day E, Fiorentino F, Brindley C, Bush J, Bloom SR. Safety and efficacy of an extended-release peptide YY analogue for obesity: A randomized, placebo-controlled, phase 1 trial. Diabetes Obes Metab. 2021 Jul;23(7):1471-1483. doi: 10.1111/dom.14358. Epub 2021 Mar 9.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Single ascending dose - Part A: Cohort A1 comprised 4 subjects (3 active and 1 placebo): each volunteer was dosed in three treatment periods (TP) with three ascending dose levels (doses 1 mg, 2 mg, 6 mg Y14), with minimum washouts of 1 week between Day 1 of each TP. Within each TP three subjects were given the study drug and one placebo (sterile 0.9% [w/v] saline. Each volunteer in Cohort A2 onwards was dosed only once.
Multiple ascending dose - Part B: Each participant received up to 5 doses
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Y14 Single Ascending Dose (A1: TP1, TP2 & TP3)
Sequential cross-over group received either Saline or 1 mg dose Y14 (A1) single dose, subcutaneous injection in the first treatment period; Saline or 2 mg dose Y14 single dose, subcutaneous injection in the second period, Saline or 6 mg dose Y14 single dose, subcutaneous injection in the third treatment period.
Treatment periods were 12-15 days apart.
FG001
9.0 mg (A2)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
FG002
9 mg (A3)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
FG003
9 mg (A4)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
FG004
18.0 mg (A5)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
FG005
36.0 mg (A6)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
FG006
18 mg (A7)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
FG007
36 mg (A8)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
FG008
36 mg (A9)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
FG009
Placebo SAD (A2-A9)
0.9% saline
Placebo: 0.9% saline
FG010
Placebo (Part B)
0.9% saline multiple subcutaneous injection:
5 injections over a 4 week treatment period
FG011
9-26.0 mg (B1)
Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating doses up to maximum 26 mg
Y14: Gut hormone analogue
FG012
9-36 mg (B2)
Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses up to maximum 36 mg
Y14: Gut hormone analogue
FG013
12-36 mg (B3)
Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses up to a maximum of 36 mg
Y14: Gut hormone analogue
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
One participant was withdrawn after treatment period 2 and a replacement subject was recruited for treatment period 3
FG0005 subjects
FG0015 subjects
FG0025 subjects
FG0035 subjects
FG004
COMPLETED
One participant was withdrawn after treatment period 2 and a replacement subject was recruited for treatment period 3
FG0004 subjects
FG0015 subjects
FG0025 subjects
FG003
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
SAD A1
Sequential cross-over group received either Saline or 1 mg dose Y14 (A1) single dose, subcutaneous injection in the first treatment period; Saline or 2 mg dose Y14 single dose, subcutaneous injection in the second period, Saline or 6 mg dose Y14 single dose, subcutaneous injection in the third treatment period. Treatment periods were 12-15 days apart.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Safety and Tolerability)
As assessed by reporting of adverse events, vital signs, physical examination, clinical laboratory safety assessments, and ECG parameters.
Possibly or definitely related to study drug
Posted
Count of Participants
Participants
Up to 73 days after dosing
ID
Title
Description
OG000
Placebo (A1)
0.9% saline single subcutaneous injection
OG001
1.0 mg (A1) TP1
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG002
2.0 mg (A1) TP2
Adverse Events Module
Frequency Threshold
0
Time Frame
Up to 21 weeks from participant start date
Description
The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
5 subcutaneous injections of 0.9% saline, over a 4 week treatment period
Drug: Placebo
9-26.0 mg (B1)
Experimental
Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating doses to a max of 26 mg
Drug: Y14
9-36 mg (B2)
Experimental
Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses to a max of 36 mg
Drug: Y14
12-36 mg (B3)
Experimental
Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses to a max of 36 mg
Drug: Y14
Placebo (A)
Placebo Comparator
Single subcutaneous injection of 0.9% saline
Drug: Placebo
9 mg Y14 (A3) with varied formulation
Experimental
Y14 single dose, subcutaneous
Drug: Y14
9 mg Y14 (A4) with varied formulation
Experimental
Y14 single dose, subcutaneous
Drug: Y14
18 mg Y14 (A7) with varied formulation
Experimental
Y14 single dose, subcutaneous
Drug: Y14
36 mg Y14 (A8) with varied formulation
Experimental
Y14 single dose, subcutaneous
Drug: Y14
36 mg Y14 (A9) with varied formulation
Experimental
Y14 single dose, subcutaneous
Drug: Y14
2.0 mg Y14 (A1)
36 mg Y14 (A8) with varied formulation
36 mg Y14 (A9) with varied formulation
36.0 mg Y14 (A6) with varied formulation
6.0 mg Y14 (A1)
9 mg Y14 (A3) with varied formulation
9 mg Y14 (A4) with varied formulation
9-26.0 mg (B1)
9-36 mg (B2)
9.0 mg Y14 (A2) with varied formulation
Gut hormone analogue
Placebo
Drug
0.9% saline
Placebo (A)
Placebo (B)
Saline
Up to 72hr after dosing
AUC 0-τ
The area under the concentration versus time curve within a (168 h) dosing interval, calculated by the mixed linear/log trapezoidal rule (equivalent to AUC0-168h, which was calculated as the area under the concentration versus time curve from time zero to 168 h post-dose after a single dose, calculated by the mixed linear/log trapezoidal rule).
Up to 168h after dosing
T 1/2
Drug Half-life (t1/2) is defined as the amount of time (hours) required for the drug concentration to be reduced to exactly half its initial concentration or amount in blood.
The apparent terminal half-life, calculated from Loge 2 / λz:
For Part A cohorts, it was not possible to estimate an unambiguous Tmax or T1/2 due to the extended PK profile of Y14.
For Part B cohorts, no individual administered dose half-life data were collected for this outcome, but one half-life value was measured after all doses had been administered and these values were analysed only for the treated-arms that is B1, B2 and B3.
For Part A, Cohorts A3 to A9 - up to 840 hour post dose. For Part B - up to day 70 post 1st dose
5 subjects
FG0055 subjects
FG0065 subjects
FG0075 subjects
FG0085 subjects
FG0098 subjects
FG0106 subjects
FG0116 subjects
FG0126 subjects
FG0136 subjects
5 subjects
FG0045 subjects
FG0055 subjects
FG0065 subjects
FG0075 subjects
FG0085 subjects
FG0098 subjects
FG0105 subjects
FG0116 subjects
FG0126 subjects
FG0136 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
BG001
9.0 mg (A2)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
BG002
9 mg (A3)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
BG003
9 mg (A4)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
BG004
18.0 mg (A5)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
BG005
36.0 mg (A6)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
BG006
18 mg (A7)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
BG007
36 mg (A8)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
BG008
36 mg (A9)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
BG009
Placebo SAD A2-A9
0.9% saline
Placebo: 0.9% saline
BG010
Placebo (Part B)
0.9% saline multiple subcutaneous injection:
5 injections over a 4 week treatment period
BG011
9-26.0 mg (B1)
Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating dose up to 26 mg
Y14: Gut hormone analogue
BG012
9-36 mg (B2)
Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating dose up to 36 mg
Y14: Gut hormone analogue
BG013
12-36 mg (B3)
Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating dose up to 36 mg.
Y14: Gut hormone analogue
BG014
Total
Total of all reporting groups
5
BG0015
BG0025
BG0035
BG0045
BG0055
BG0065
BG0075
BG0085
BG0098
BG0106
BG0116
BG0126
BG0136
BG01477
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049.2± 13.44
BG00128.2± 5.02
BG00247.8± 10.8
BG00341.2± 13.3
BG00445.6± 14.9
BG00547.8± 1.5
BG00640.4± 13.3
BG00744.2± 12.5
BG00837.0± 12.2
BG00944.8± 11.5
BG01049.5± 11.9
BG01136.7± 10.0
BG01242.3± 9.6
BG01340.8± 9.7
BG01442.6± 11.6
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Male
BG0005
BG0015
BG0025
BG0035
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Asian
BG0000
BG0010
BG0020
BG0031
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0011
BG0021
BG0030
BG004
White
BG0005
BG0014
BG0024
BG0034
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United Kingdom
Title
Measurements
BG0005
BG0015
BG0025
BG0035
BG0045
BG0055
BG0065
BG0075
BG0085
BG0098
BG0106
BG0116
BG0126
BG0136
BG01477
Body Weight (kg)
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00089.0± 12.41
BG001101.6± 12.7
BG002100.4± 11.3
BG00386.2± 11.78
BG004101.6± 9.6
BG00593.3± 5.60
BG00687.4± 13.3
BG00792.4± 16.47
BG00888.6± 7.4
BG00997.5± 14.9
BG01093.2± 14.8
BG01197.5± 14.0
BG01295.2± 9.8
BG01392.0± 8.1
BG01492.0± 12.09
BMI (kg/m^2)
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00029.2± 2.05
BG00130.0± 2.70
BG00230.8± 1.9
BG00327.6± 2.4
BG00430.6± 1.8
BG00528.8± 1.87
BG00627.0± 2.9
BG00730.6± 4.2
BG00826.6± 0.9
BG00930.1± 2.9
BG01029.7± 3.1
BG01130.2± 3.9
BG01230.2± 2.9
BG01329.5± 2.1
BG01429.3± 2.7
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG003
6.0 mg (A1) TP3
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG004
9 mg (A4)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG005
9 mg (A3)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG006
9.0 mg (A2)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG007
18 mg (A7)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG008
18.0 mg (A5)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG009
36 mg (A8)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG010
36.0 mg (A6)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG011
36 mg (A9)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG012
Placebo SAD A2-A9
0.9% saline
Placebo: 0.9% saline
OG013
Placebo (Part B)
0.9% saline multiple subcutaneous injection:
5 injections over a 4 week treatment period
OG014
9 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG015
9 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG016
12 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG017
12 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG018
16 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG019
20 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG020
24 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG021
24 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG022
26 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG023
36 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG024
36 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0045
OG0055
OG0065
OG0075
OG0085
OG0095
OG0105
OG0115
OG0128
OG0136
OG0146
OG0156
OG0166
OG0176
OG0186
OG0196
OG0206
OG0216
OG0226
OG0236
OG0246
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0021
OG0033
OG0045
OG0054
OG0061
OG0075
OG0085
OG0094
OG0105
OG0115
OG0123
OG0133
OG0145
OG0154
OG0166
OG0175
OG0186
OG0196
OG0206
OG0215
OG0226
OG0235
OG0246
Secondary
Cmax
The maximum observed concentration
PK Parameters: N/A= For the doses given to cohorts A1, A2 and A3, Y14 was below the LLOQ(<0.2 ng/mL) in most samples (BLQ=below the limit of quantification), so the data for cohort A4 onwards are presented. Only subjects receiving Y14 were analysed
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
For Part A, Cohorts A3 to A9 - up to 840 hour post dose. For Part B - up to day 70 post 1st dose
ID
Title
Description
OG000
Placebo (A1)
0.9% saline single subcutaneous injection
OG001
1.0 mg (A1) TP1
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG002
2.0 mg (A1) TP2
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG003
6.0 mg (A1) TP3
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG004
9.0 mg (A2)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG005
9 mg (A3)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG006
9 mg (A4)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG007
18.0 mg (A5)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG008
36.0 mg (A6)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG009
18 mg (A7)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG010
36 mg (A8)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG011
36 mg (A9)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG012
Placebo SAD A2-A9
0.9% saline
Placebo: 0.9% saline
OG013
Placebo (Part B)
0.9% saline multiple subcutaneous injection:
5 injections over a 4 week treatment period
OG014
9 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG015
12 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG016
16 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG017
20 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG018
26 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG019
9 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG020
24 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG021
36 mg Y14 (B2) 1st Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG022
36mg Y14 (B2) 2nd Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG023
12 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG024
24 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG025
36 mg Y14 (B3) 1st Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG026
36 mg Y14 (B3) 2nd Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NABLQ
OG001NA± NABLQ
OG002NA± NABLQ
OG003
Secondary
AUC 0-72h
The area under the concentration versus time curve from time zero to 72 h postdose, calculated by the mixed linear/log trapezoidal rule
PK Parameters: N/A = For the doses given to cohorts A1, A2, A3 and A5, Y14 was below the LLOQ(<0.2 ng/mL) in most samples (BLQ=below the limit of quantification), so the data for cohort A4 and cohort A6 onwards are presented. Only subjects receiving Y14 were analysed
Posted
Geometric Mean
Geometric Coefficient of Variation
ng.h/mL
Up to 72hr after dosing
ID
Title
Description
OG000
Placebo (A1)
0.9% saline single subcutaneous injection
OG001
1.0 mg (A1) TP1
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG002
2.0 mg (A1) TP2
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG003
6.0 mg (A1) TP3
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG004
9.0 mg (A2)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG005
9 mg (A3)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG006
9 mg (A4)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG007
18.0 mg (A5)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG008
36.0 mg (A6)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG009
18 mg (A7)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG010
36 mg (A8)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG011
36 mg (A9)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG012
Placebo SAD A2-A9
0.9% saline
Placebo: 0.9% saline
OG013
Placebo (Part B)
0.9% saline multiple subcutaneous injection:
5 injections over a 4 week treatment period
OG014
9 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG015
12 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG016
16 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG017
20 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG018
26 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG019
9 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG020
24 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG021
36 mg Y14 (B2) 1st Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG022
36mg Y14 (B2) 2nd Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG023
12 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG024
24 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG025
36 mg Y14 (B3) 1st Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG026
36 mg Y14 (B3) 2nd Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NABLQ
OG001NA± NABLQ
OG002NA± NABLQ
OG003
Secondary
AUC 0-τ
The area under the concentration versus time curve within a (168 h) dosing interval, calculated by the mixed linear/log trapezoidal rule (equivalent to AUC0-168h, which was calculated as the area under the concentration versus time curve from time zero to 168 h post-dose after a single dose, calculated by the mixed linear/log trapezoidal rule).
PK Parameters: N/A = For the doses given to cohorts A1, A2, A3 and A4, Y14 was below the LLOQ(<0.2 ng/mL) in most samples (BLQ=below the limit of quantification), so the data for cohort A5 onwards are presented. Only subjects receiving Y14 were analysed
Posted
Geometric Mean
Geometric Coefficient of Variation
ng.h/mL
Up to 168h after dosing
ID
Title
Description
OG000
Placebo (A1)
0.9% saline single subcutaneous injection
OG001
1.0 mg (A1) TP1
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG002
2.0 mg (A1) TP2
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG003
6.0 mg (A1) TP3
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG004
9.0 mg (A2)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG005
9 mg (A3)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG006
9 mg (A4)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG007
18.0 mg (A5)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG008
36.0 mg (A6)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG009
18 mg (A7)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG010
36 mg (A8)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG011
36 mg (A9)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG012
Placebo SAD A2-A9
0.9% saline
Placebo: 0.9% saline
OG013
Placebo (Part B)
0.9% saline multiple subcutaneous injection:
5 injections over a 4 week treatment period
OG014
9 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG015
12 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG016
16 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG017
20 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG018
26 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG019
9 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG020
24 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG021
36 mg Y14 (B2) 1st Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG022
36mg Y14 (B2) 2nd Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG023
12 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG024
24 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG025
36 mg Y14 (B3) 1st Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
OG026
36 mg Y14 (B3) 2nd Dose
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NABLQ
OG001NA± NABLQ
OG002NA± NABLQ
OG003
Secondary
T 1/2
Drug Half-life (t1/2) is defined as the amount of time (hours) required for the drug concentration to be reduced to exactly half its initial concentration or amount in blood.
The apparent terminal half-life, calculated from Loge 2 / λz:
For Part A cohorts, it was not possible to estimate an unambiguous Tmax or T1/2 due to the extended PK profile of Y14.
For Part B cohorts, no individual administered dose half-life data were collected for this outcome, but one half-life value was measured after all doses had been administered and these values were analysed only for the treated-arms that is B1, B2 and B3.
PK Parameters:
NA= Values below the limit of quantification (BLQ) For the doses given to cohorts in Part A, Y14 was below the lower limit of quantification (<0.2 ng/mL) in most samples and it was not possible to estimate an unambiguous Tmax or T1/2 due to the extended PK profile of Y14. Therefore the data for Part B only are presented.
Participants who received placebo were not assessed for this measure, therefore only subjects receiving Y14 were analysed
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
For Part A, Cohorts A3 to A9 - up to 840 hour post dose. For Part B - up to day 70 post 1st dose
ID
Title
Description
OG000
Placebo (A1)
0.9 % saline single subcutaneous injection
OG001
1.0 mg (A1) TP1
Y14 single dose, subcutaneous Y14: Gut hormone analogue
OG002
2.0 mg (A1) TP2
Y14 single dose, subcutaneous Y14: Gut hormone analogue
OG003
6.0 mg (A1) TP3
Y14 single dose, subcutaneous Y14: Gut hormone analogue
OG004
9.0 mg (A2)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG005
9 mg (A3)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG006
9 mg (A4)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG007
18.0 mg (A5)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG008
36.0 mg (A6)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG009
18 mg (A7)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG010
36 mg (A8)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG011
36 mg (A9)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
OG012
Placebo SAD (A2-A9)
0.9% saline
Placebo: 0.9% saline
OG013
Placebo (Part B)
0.9% saline multiple subcutaneous injection:
5 injections over a 4 week treatment period
OG014
9-26.0 mg (B1)
Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating doses up to maximum 26 mg
Y14: Gut hormone analogue
OG015
9-36 mg (B2)
Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses up to maximum 36 mg
Y14: Gut hormone analogue
OG016
12-36 mg (B3)
Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses up to a maximum of 36 mg
Y14: Gut hormone analogue
Units
Counts
Participants
OG0000
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG001NA± NANot available: Below the limit of quantification (BLQ)
OG002NA± NANot available (BLQ)
OG003NA± NANot available (BLQ)
3
0
3
2
3
EG001
1.0 mg (A1) TP1
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
3
0
3
1
3
EG002
2.0 mg (A1) TP2
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
3
0
3
1
3
EG003
6.0 mg (A1) TP3
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
3
0
3
3
3
EG004
Placebo SAD (A2-A9)
0.9% saline
Placebo: 0.9% saline
0
8
0
8
3
8
EG005
9 mg (A4)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
5
0
5
5
5
EG006
9 mg (A3)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
5
0
5
4
5
EG007
9.0 mg (A2)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
5
0
5
1
5
EG008
18 mg (A7)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
5
0
5
5
5
EG009
18.0 mg (A5)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
5
0
5
5
5
EG010
36 mg (A8)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
5
0
5
4
5
EG011
36.0 mg (A6)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
5
0
5
5
5
EG012
36 mg (A9)
Y14 single dose, subcutaneous
Y14: Gut hormone analogue
0
5
0
5
5
5
EG013
Placebo (Part B)
0.9% saline multiple subcutaneous injection:
5 injections over a 4 week treatment period
0
6
0
6
3
6
EG014
9 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
0
6
0
6
5
6
EG015
9 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
0
6
0
6
4
6
EG016
12 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
0
6
0
6
6
6
EG017
12 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
0
6
0
6
5
6
EG018
16 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
0
6
0
6
6
6
EG019
20 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
0
6
0
6
6
6
EG020
24 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
0
6
0
6
6
6
EG021
24 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
0
6
0
6
5
6
EG022
26 mg Y14 (B1)
Y14 multiple dose, subcutaneous injection:
1 of 5 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
0
6
0
6
6
6
EG023
36 mg Y14 (B2)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.
Y14: Gut hormone analogue
0
6
0
6
5
6
EG024
36 mg Y14 (B3)
Y14 multiple dose, subcutaneous injection:
1 of 4 doses over a 4 week treatment period at escalating doses.