Safety and Pharmacokinetic Study of Y242 in Adult Subjects

NCT01515319 | Completed Phase 1 Results DMC

• 2 other identifiers: QLON/2011/Y242-012011-003549-17
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Obesity

Keywords

Obesity; Peptide YY; Food intake; Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 73 days

Secondary Outcomes (1)

• Body Weight

  up to 32 day

Study Arms (10)

2mg Y242 (Part A)

EXPERIMENTAL

Y242 single dose, subcutaneous

Drug: Y242

7.5mg Y242 (Part A)

EXPERIMENTAL

Y242 single dose, subcutaneous

Drug: Y242

15mg Y242 (Part A)

EXPERIMENTAL

Y242 single dose, subcutaneous

Drug: Y242

30mg Y242 (Part A)

EXPERIMENTAL

Y242 single dose, subcutaneous

Drug: Y242

60mg Y242 (Part A)

EXPERIMENTAL

Y242 single dose, subcutaneous

Drug: Y242

90mg Y242 (Part A)

EXPERIMENTAL

Y242 single dose, subcutaneous

Drug: Y242

Placebo - Part A

PLACEBO COMPARATOR

0.9% saline

Drug: 0.9% saline

60mg Y242 (Part B1)

EXPERIMENTAL

Y242 single subcutaneous dose, administered once a week for 5 weeks

Drug: Y242

90mg Y242 (Part B2-B4)

EXPERIMENTAL

Y242 single subcutaneous dose, administered once a week for 5 weeks

Drug: Y242

Placebo - Part B

PLACEBO COMPARATOR

0.9% saline

Drug: 0.9% saline

Interventions

Y242 DRUG

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)

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% saline DRUG

Identical volume to that of Y242

Placebo - Part A; Placebo - Part B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Adult males aged 18 to 50 years inclusive with BMI between 23.0 and 30.0 kg/m\^2 inclusive
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Imperial College London: lead
• Medical Research Council: collaborator

Study Sites (1)

PAREXEL Early Phase Clinical Unit

London, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr Tricia Tan
• Organization: Imperial College London

t.tan@imperial.ac.uk

020 838 38038

Study Officials

• Stephen Bloom DSc, MD FRCP

  Imperial College London

  STUDY CHAIR

• John Lambert, MBBS PhD

  Parexel

  PRINCIPAL INVESTIGATOR

• Tricia Tan BSc MRCP, MB ChB

  Imperial College London

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part A: Treatments were administered single-blind; subjects were blinded with regard to treatment and clinical staff remained blinded with regard to treatment until the Safety Committee meeting. Part B was double blind.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 24, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)