A Study to Evaluate AZP531 in Healthy Volunteers, Overweight/Obese Volunteers and Patients With Type 2 Diabetes Mellitus

Phase 1

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: AZP-531

• Registration Number: NCT02040012
• Lead Sponsor: Alizé Pharma

Brief Summary

Objectives:

Primary Objectives

* To investigate the safety and tolerability of single ascending doses of AZP- 531 in healthy volunteers.

* To investigate the safety and tolerability of single and multiple ascending doses of AZP-531 in overweight/obese volunteers.

* To investigate the safety and tolerability of single and multiple ascending doses of AZP-531 in patients with type 2 diabetes mellitus.

Secondary Objectives • To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses.

Exploratory Objectives

• To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers of blood glucose, interstitial glucose, insulin, and plasma acylated ghrelin (AG) and unacylated ghrelin (UAG)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Part A: Healthy male volunteers, aged 18 to 50 years (inclusive) with a body mass index (BMI) of 20 to 28 kg/m2 (inclusive).
• Part B: Female (of non-childbearing potential) and male overweight/obese volunteers, aged 18 to 65 years (inclusive) with a BMI of 28 to 38 kg/m2 (inclusive).
• Part C: Female (of non-childbearing potential) and male patients with a confirmed diagnosis of type 2 diabetes mellitus for at least 3 months

Exclusion Criteria

• Part A: Females and male volunteers who smoke and/or use other nicotine products within 6 months of screening are excluded.
• Part B: Current or ex-smokers with a smoking history of greater than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) and any clinically significant abnormalities in physical examination, electrocardiogram (ECG), clinical chemistry, haematology, coagulation or urinalysis results at screening or on admission, as judged by the Investigator.
• Part C: Current or ex-smokers with a smoking history of greater than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year), any clinically significant abnormalities other than those attributed to type 2 diabetes mellitus in physical examination, ECG, clinical chemistry, haematology, coagulation or urinalysis results at screening or on admission, as judged by the Investigator, and estimated glomerular filtration rate <40 mL*min-1*1.73m-2 calculated by the Modification of Diet in Renal Disease formula.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mannitol	Placebo	subcut administration once or twice daily
AZP-531	AZP-531	subcut administration once or twice daily

Primary Outcome Measures

Name	Time	Method
To investigate the number of adverse events of single and multiple ascending doses AZP-531 in healthy volunteers, in overweight/obese volunteers, in patients with type 2 diabetes mellitus.	1 to 14 days

Secondary Outcome Measures

Name	Time	Method
To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses	1 to 14 days

Trial Locations

Locations (1)

Quintiles Drug Research Unit at Guy's Hospital; 🇬🇧 London, United Kingdom