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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-10-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZP-531

subcut administration once or twice daily

Group Type ACTIVE_COMPARATOR

AZP-531

Intervention Type DRUG

Mannitol

subcut administration once or twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZP-531

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes