A randomised, placebo controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an Oxyntomodulin analogue (G3215) delivered via a subcutaneous infusion in adult subjects

Imperial College London0 sites24 target enrollmentNovember 3, 2020

ConditionsDiabetes Mellitus Obesity Nutritional, Metabolic, Endocrine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Diabetes Mellitus Obesity
Sponsor: Imperial College London
Enrollment: 24
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2024 Results article in https://doi.org/10.1111/dom.15448 (added 18/01/2024)

Registry

who.int

Start Date

November 3, 2020

End Date

October 22, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Imperial College London

Eligibility Criteria

Inclusion Criteria

•Current inclusion criteria as of 07/09/2021:
•1\. Adult males aged 18 to 65 years inclusive with BMI between 25\.0 and 45\.0 kg/m² inclusive
•2\. Subjects may have normal glucose tolerance, Type 2 diabetes, impaired glucose tolerance or impaired fasting glucose according to WHO 2006 and 2011 criteria
•3\. The following criteria apply to subjects with Type 2 diabetes, impaired glucose tolerance or impaired fasting glucose according to WHO 2006 and 2011 criteria
•3\.1\. They should be stably treated either with:
•3\.1\.1\. Diet and lifestyle changes only
•3\.1\.2\. Monotherapy with a sulphonylurea, metformin, or SGLT\-2 inhibitor; or
•3\.1\.3\. Dual therapy with sulphonylurea/metformin, or sulphonylurea/SGLT\-2 inhibitor
•3\.2\. Patients treated with triple anti\-diabetic treatments are excluded
•3\.3\. The HbA1c at screening should be 6\.0–8\.5% (42–69 mmol/mol) and \<±1\.0% (±11 mmol/mol) from a previous HbA1c reading within the last 6 months, where available. Where an HbA1c reading within the last 6 months is not available, the subject should have HbA1c re\-measured after at least 4 weeks to assure stability of glycaemia before inclusion in the study. This remeasurement may take place any time up to and including check in on Day \-1

Exclusion Criteria

•1\. Subjects who do not conform to the above inclusion criteria
•2\. Subjects who have a 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 that in the Investigator’s opinion will compromise safety, practicability or scientific value of the study
•3\. Subjects who have a relevant surgical history that in the Investigator’s opinion will compromise safety, practicability or scientific value of the study
•4\. Subjects who have used prescription drugs within 4 weeks of first dosing, with the following exceptions:
•a. Anti\-diabetic drugs as specified in the inclusion criteria.
•b. Hypolipidaemic and/or antihypertensive treatments, provided that the doses have not been altered within the 4 weeks prior to entering the study.
•c. Other medications may be allowed if the Investigator judges that they will not affect the outcome of the study or the safety of the subject.
•5\. 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 Investigator and Sponsor
•6\. 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 glucorticoids 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)
•7\. Subjects who have a history of relevant drug hypersensitivity