CClinicalTrials.gg
Status unknownNCT02040012Updated Jun 18, 2015

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

A Phase 1 interventional study of AZP-531 and Placebo in Type 2 Diabetes Mellitus, sponsored by Alizé Pharma. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-18.

Sponsored by Alizé Pharma · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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)
02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 108 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Alizé Pharma as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • Active comparator
    AZP-531

    subcut administration once or twice daily

    Drug: AZP-531

  • Placebo comparator
    Mannitol

    subcut administration once or twice daily

    Drug: Placebo

Interventions

  • DrugAZP-531
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 to 14 days

Secondary outcomes

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

    Time frame: 1 to 14 days

Other outcomes

  1. To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers

    Time frame: 1 to 14 days

07

Study locations

1 site
  • Quintiles Drug Research Unit at Guy's Hospital
    London, SE1 1YR, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02040012
Lead sponsor
Alizé Pharma
Responsible party
Sponsor
First posted
Jan 20, 2014
Start date
Jul 2013
Primary completion
Oct 2015 (estimated)
Completion
Oct 2015 (estimated)
Last update
Jun 18, 2015

Study contacts

James Ritter, MD Professor
principal investigator · Quintiles Drug Research Unit at Guy's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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