A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity

Purpose

The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ascending doses in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.

Conditions

  • Healthy Participants
  • Obesity

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. - Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. - Have a body mass index between 25 and 39.9 kg/m2 (Global cohorts [Parts A1 and B1]), or 23 and 39.9 kg/m2 (Japanese [Parts A2 and B2] and Chinese [Part A3] cohorts) inclusive and weigh at least 50 kg. - For the Parts A2 and B2, participants should be Japanese (natives of Japan or Japanese Americans), having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan. - For the Part A3, participants should be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.

Exclusion Criteria

  • History of any clinically important disease or disorder. - History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. - Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. - Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs. - History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs of a similar class to AZD1043. - Has received prescription or non-prescription medication for weight loss within the last 3 months. - History of psychosis or bipolar disorder or major depressive disorder within the past 2 years with the participant being clinically unstable.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1) 		Participants will receive a single dose of AZD1043 (Dose 1) or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2) 		Participants will receive a single dose of AZD1043 (Dose 2) or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3) 		Participants will receive a single dose of AZD1043 (Dose 3) or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4) 		Participants will receive a single dose of AZD1043 (Dose 4) or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5) 		Participants will receive a single dose of AZD1043 (Dose 5) or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6) 		Participants will receive a single dose of AZD1043 (Dose 6) or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X) 		Japanese participants will receive a single dose of AZD1043 or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y) 		Japanese participants will receive a single dose of AZD1043 or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z) 		Chinese participants will receive a single dose of AZD1043 or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A) 		Participants will receive multiple doses of AZD1043 or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B) 		Participants will receive multiple doses of AZD1043 or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C) 		Participants will receive multiple doses of AZD1043 or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.
Experimental
Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D) 		Japanese participants will receive multiple doses of AZD1043 or placebo.
  • Drug: AZD1043
    Single or multiple doses of AZD1043 will be administered.
  • Other: Placebo
    Matching placebo to AZD1043 will be administered.

Recruiting Locations

Research Site
Glendale, California 91206

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

This is a phase 1, first time in human (FTiH) randomized, single-blind, placebo-controlled study in healthy male and female participants living with overweight and/or obesity, with female participants being of non-childbearing potential. It consists of 2 parts: Part A (single ascending doses: SAD): This will consist of Part A1 (Global SAD (GSAD)) with 6 cohorts, Part A2 (Japanese SAD (JSAD)) with 2 cohorts and Part A3 (Chinese SAD (CSAD)) with 1 cohort. Part B (multiple ascending doses: MAD): This will consist of Part B1 (Global MAD (GMAD)) with 3 cohorts and Part B2 (Japanese MAD (JMAD)) with 1 cohort. Participants are only allowed to participate in one of the cohorts. Both Part A and Part B will comprise of: - Screening period (up to 5 weeks). - Treatment period. - Safety follow-up period.