AZD7687 Multiple Ascending Dose Study

A Phase 1, Single Centre, Single-Blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Multiple Ascending Doses in Overweight to Obese But Otherwise Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01119352

Enrollment

Registered

2010-05-07

Start date

2010-04-30

Completion date

2011-03-31

Last updated

2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese, Overweight

Keywords

Safety, tolerability, PK, healthy, overweight, obese

Brief summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD7687 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects

Interventions

DRUGAZD7687

Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses.

DRUGPlacebo

Oral suspension, once daily. Totally 8 doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures * suitable veins for cannulation or repeated venepuncture. * Have a body mass index (BMI) between 27 and 35 kg/m2

Exclusion criteria

* Fasting serum (S)-glucose ≥7.0 mmol/L or non-fasting S-glucose ≥11.1 mmol/L at screening. * Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment. * Smoking more than 7 cigarettes per week from time of consent

Design outcomes

Primary

Measure	Time frame
Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)	Before, during and after dosing.

Secondary

Measure	Time frame
Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters	Information will be collected from the time of day -2 throughout the study.
Pharmacodynamic Biomarker sampling: (Triacylglycerol in serum, triacylglycerol, diacylglycerol, insulin and free fatty acids in plasma. Triacylglycerol and diacylglycerol in adipose tissue)	Information will be collected from the time of day -2 throughout the study.
Genetic: Blood sampling at one occasion during the study.	Once during study

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026