ObesityPhase 1Y242-01NCT01515319
Safety and Pharmacokinetic Study of Y242 in Adult Subjects
A Phase 1 study testing Y242 and 0.9% saline in people with Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Obesity causes 600 premature deaths per week in the UK and existing treatments are not effective. When humans eat, the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating. One of these chemicals is known as Peptide YY (PYY). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Y242 and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Feb 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males aged 18 to 50 years inclusive with BMI between 23.0 and 30.0 kg/m^2 inclusive;
- Subjects who are healthy 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 are able and willing to give written informed consent.
Who cannot join
- 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 have a clinically relevant family history;
- Subjects who have a history of relevant atopy;
- Subjects who have a history of relevant drug hypersensitivity;
Show all 23Show fewer
- Subjects who have a history of alcoholism;
- Subjects who have a history of drug abuse;
- Subjects who have a history of migraine;
- 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 4 weeks of first dosing;
- 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 or blood products within 3 months of Day -2 (admission);
- Subjects who have used any investigational drug in any clinical trial within 3 months of Day -2 (admission);
- 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 Y242;
- Subjects who are vegans or have any dietary restrictions;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Y242 in Adult Subjects
Obesity causes 600 premature deaths per week in the UK and existing treatments are not effective. When humans eat, the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating. One of these chemicals is known as Peptide YY (PYY). The investigators have previously shown that injections of PYY reduce appetite and food intake in human volunteers. The investigators have now developed a very similar chemical, Y242, as a treatment for obesity. Y242 has been tested in animals and has been shown to be safe, to reduce their appetite, and to last for much longer than PYY itself. This study will test Y242 to ensure that it is well tolerated in humans, and to see how long it lasts in the blood stream after being injected under the skin. It will also look for any effects on appetite.
Read the detailed description
Obesity causes 600 premature deaths per week in the UK and existing treatments are less than ideal. Intravenous infusion of a hormone called PYY reduces food intake but its effects only last for a few hours and it can cause nausea. Y242 is a longacting analogue of PYY. Given subcutaneously in rodents, it has a profile of action of at least 72 hours and strongly inhibits food intake. It causes weight loss without behavioural effects. With MRC funding, Y242 has passed Good Laboratory Practice toxicology testing and the present proposal is a first in human study to investigate its safety, tolerability and pharmacokinetics in overweight but otherwise healthy men.
The study is a combined single ascending dose (part A) and multiple ascending dose (part B) Phase 1 investigation. The primary objective is to investigate safety and tolerability. The secondary objective is to assess Y242's pharmacokinetic (PK) profile. Possible effects on food consumption will be explored. For part A up to 48 subjects are planned, with up to 40 subjects for part B. In each part subjects are divided into groups, each of which is dosed with the same level, starting with a single dose (part A) much lower than is expected to cause an effect. Subjects are admitted to a Unit so they can be closely observed for adverse effects and safety tests, blood concentrations of the drug and food and liquid intake and output will be monitored. Subjects are allocated at random (like tossing a coin) to receive Y242 or placebo (dummy). Safety, tolerability and pharmacokinetic data will be summarised and available results considered in deciding dose escalation, with stopping rules designed to enable us to explore the relationship between dose and adverse effect (eg nausea) without causing unacceptable nausea or other symptoms in the volunteers.
- Conditions
- Obesity
- Being tested
- Y242, 0.9% saline
- Keywords
- Obesity, Peptide YY, Food intake, Safety, Pharmacokinetics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y242Drug
Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)
0.9% salineDrug
Identical volume to that of Y242
| Study group | Role | What they receive |
|---|---|---|
| 2mg Y242 (Part A) | Experimental | Y242 single dose, subcutaneous Receives: Drug: Y242 |
| 7.5mg Y242 (Part A) | Experimental | Y242 single dose, subcutaneous Receives: Drug: Y242 |
| 15mg Y242 (Part A) | Experimental | Y242 single dose, subcutaneous Receives: Drug: Y242 |
| 30mg Y242 (Part A) | Experimental | Y242 single dose, subcutaneous Receives: Drug: Y242 |
| 60mg Y242 (Part A) | Experimental | Y242 single dose, subcutaneous Receives: Drug: Y242 |
| 90mg Y242 (Part A) | Experimental | Y242 single dose, subcutaneous Receives: Drug: Y242 |
| Placebo - Part A | Placebo comparator | 0.9% saline Receives: Drug: 0.9% saline |
| 60mg Y242 (Part B1) | Experimental | Y242 single subcutaneous dose, administered once a week for 5 weeks Receives: Drug: Y242 |
| 90mg Y242 (Part B2-B4) | Experimental | Y242 single subcutaneous dose, administered once a week for 5 weeks Receives: Drug: Y242 |
| Placebo - Part B | Placebo comparator | 0.9% saline Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)
A treatment-emergent AE (TEAE) as defined as an AE that started after administration of IMP; in Part B this was an AE that started after the first dose of IMP. Adverse events with onset prior to dosing were considered as pre-treatment AEs.
Measured: Up to 73 days
Secondary outcomes (1)
Body Weight
Summary of Time-Matched % Change from Baseline in Body Weight (Baseline = Day -1) following multiple dose of Y242 (Part B)
Measured: up to 32 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A was a single blind, randomised, placebo controlled, single ascending dose (SAD) study. Part B was a double blind, randomised, placebo controlled, multiple ascending dose (MAD) study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Stephen Bloom DSc, MD FRCP, Study chair, Imperial College LondonJohn Lambert, MBBS PhD, Principal investigator, ParexelTricia Tan BSc MRCP, MB ChB, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515319
- Sponsor's protocol ID
- QLON/2011/Y242-01
- Other IDs
- 2011-003549-17
- Acronym
- Y242-01
- Status last verified
- Jan 2021
- First submitted
- 22 Dec 2011
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Y242 in Adult Subjects
- ClinicalTrials.gov ID
- NCT01515319
- Acronym / sponsor ID
- Y242-01 / QLON/2011/Y242-01
- Conditions
- Obesity
- Keywords
- Obesity, Peptide YY, Food intake, Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Apr 2012 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Posted 8 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity causes 600 premature deaths per week in the UK and existing treatments are not effective. When humans eat, the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating. One of these chemicals is known as Peptide YY (PYY). The investigators have previously shown that injections of PYY reduce appetite and food intake in human volunteers. The investigators have now developed a very similar chemical, Y242, as a treatment for obesity. Y242 has been tested in animals and has been shown to be safe, to reduce their appetite, and to last for much longer than PYY itself. This study will test Y242 to ensure that it is well tolerated in humans, and to see how long it lasts in the blood stream after being injected under the skin. It will also look for any effects on appetite.
Detailed description
Obesity causes 600 premature deaths per week in the UK and existing treatments are less than ideal. Intravenous infusion of a hormone called PYY reduces food intake but its effects only last for a few hours and it can cause nausea. Y242 is a longacting analogue of PYY. Given subcutaneously in rodents, it has a profile of action of at least 72 hours and strongly inhibits food intake. It causes weight loss without behavioural effects. With MRC funding, Y242 has passed Good Laboratory Practice toxicology testing and the present proposal is a first in human study to investigate its safety, tolerability and pharmacokinetics in overweight but otherwise healthy men.
The study is a combined single ascending dose (part A) and multiple ascending dose (part B) Phase 1 investigation. The primary objective is to investigate safety and tolerability. The secondary objective is to assess Y242's pharmacokinetic (PK) profile. Possible effects on food consumption will be explored. For part A up to 48 subjects are planned, with up to 40 subjects for part B. In each part subjects are divided into groups, each of which is dosed with the same level, starting with a single dose (part A) much lower than is expected to cause an effect. Subjects are admitted to a Unit so they can be closely observed for adverse effects and safety tests, blood concentrations of the drug and food and liquid intake and output will be monitored. Subjects are allocated at random (like tossing a coin) to receive Y242 or placebo (dummy). Safety, tolerability and pharmacokinetic data will be summarised and available results considered in deciding dose escalation, with stopping rules designed to enable us to explore the relationship between dose and adverse effect (eg nausea) without causing unacceptable nausea or other symptoms in the volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
- Model description
- Part A was a single blind, randomised, placebo controlled, single ascending dose (SAD) study. Part B was a double blind, randomised, placebo controlled, multiple ascending dose (MAD) study
| Arm | Type | Receives |
|---|---|---|
| 2mg Y242 (Part A) | Experimental | Drug: Y242Y242 single dose, subcutaneous |
| 7.5mg Y242 (Part A) | Experimental | Drug: Y242Y242 single dose, subcutaneous |
| 15mg Y242 (Part A) | Experimental | Drug: Y242Y242 single dose, subcutaneous |
| 30mg Y242 (Part A) | Experimental | Drug: Y242Y242 single dose, subcutaneous |
| 60mg Y242 (Part A) | Experimental | Drug: Y242Y242 single dose, subcutaneous |
| 90mg Y242 (Part A) | Experimental | Drug: Y242Y242 single dose, subcutaneous |
| Placebo - Part A | Placebo comparator | Drug: 0.9% saline0.9% saline |
| 60mg Y242 (Part B1) | Experimental | Drug: Y242Y242 single subcutaneous dose, administered once a week for 5 weeks |
| 90mg Y242 (Part B2-B4) | Experimental | Drug: Y242Y242 single subcutaneous dose, administered once a week for 5 weeks |
| Placebo - Part B | Placebo comparator | Drug: 0.9% saline0.9% saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult males aged 18 to 50 years inclusive with BMI between 23.0 and 30.0 kg/m^2 inclusive;
- Subjects who are healthy 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;
Key exclusion criteria (23 listed)
- 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 have a clinically relevant family history;
- Subjects who have a history of relevant atopy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Y242Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) | Drug | 15mg Y242 (Part A), 2mg Y242 (Part A), 30mg Y242 (Part A), 60mg Y242 (Part A), 60mg Y242 (Part B1), 7.5mg Y242 (Part A), 90mg Y242 (Part A), 90mg Y242 (Part B2-B4) |
| 0.9% salineIdentical volume to that of Y242 | Drug | Placebo - Part A, Placebo - Part B |
Primary outcome
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 73 days
A treatment-emergent AE (TEAE) as defined as an AE that started after administration of IMP; in Part B this was an AE that started after the first dose of IMP. Adverse events with onset prior to dosing were considered as pre-treatment AEs.
1 secondary outcome
Body Weight
Time frame: up to 32 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Bloom DSc, MD FRCP study chair
Imperial College London
John Lambert, MBBS PhD principal investigator
Parexel
Tricia Tan BSc MRCP, MB ChB study director
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Y242 and 0.9% saline in people with Obesity, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 73 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.