Skip to main content
Back to Trials
NCT07776509PHASE3Recruiting

A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus

AstraZeneca

Start Date

8/24/2026

Completion Date

8/9/2028

Summary

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment.

Detailed Description

This is a Phase III, global, randomised, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 as an adjunct to incretin-based therapies, compared with placebo in adults with obesity or overweight with at least one weight-related comorbidity and with or without Type 2 Diabetes Mellitus (T2DM). Eligible participants will be randomised to either receive AZD6234 or matching placebo respectively. Study treatment (AZD6234 or placebo) will be added on to the participant's stable dose of background incretin-based therapies.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Males \& females (inclusive of all gender identities) age ≥18 years * BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence * For participants with T2DM only: * Diagnosed with T2DM ≥ 90 days prior to Screening * HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication * Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation. * Stable body weight (≤ 3% body weight change) for at least 3 months prior to Randomisation * History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime Exclusion Criteria: * Obesity primarily caused by other endocrine disorders * Type 1 diabetes mellitus * Significant hepatobiliary disease and/or any of the following results at Screening: * ALT ≥ 3.0 × ULN * AST ≥ 3.0 × ULN * TBL \> 1.5 × ULN (except for cases of known Gilbert's Syndrome) * Use of insulin therapy for T2DM within 3 months prior to screening

Interventions

DRUG

Lenbelintide

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Obesity or OverweightWeight-Related ComorbidityWith/Without Diabetes Mellitus, Type 2

Locations

Research Site

Escondido, California 92025

United States

Research Site

Lincoln, California 95648

United States

Research Site

Walnut Creek, California 94598

United States

Research Site

Jacksonville, Florida 32204

United States

Research Site

Jacksonville, Florida 32205

United States

Research Site

Stockbridge, Georgia 30281

United States

Research Site

Woodstock, Georgia 30189

United States

Research Site

Champaign, Illinois 61822

United States

Research Site

Chicago, Illinois 60640

United States

Research Site

Beltsville, Maryland 20705

United States

Research Site

Oxon Hill, Maryland 20745

United States

Research Site

Kansas City, Missouri 64111

United States

Research Site

Las Vegas, Nevada 89101

United States

Research Site

Somerset, New Jersey 08873

United States

Research Site

Statesville, North Carolina 28625

United States

Research Site

Fargo, North Dakota 58104

United States

Research Site

Columbus, Ohio 43215

United States

Research Site

Portland, Oregon 97202

United States

Research Site

Smithfield, Pennsylvania 15478

United States

Research Site

Franklin, Tennessee 37067

United States

Research Site

Houston, Texas 77043

United States

Research Site

Manassas, Virginia 20110

United States

Research Site

Renton, Washington 98057

United States

Research Site

Buenos Aires, C1120AAC

Argentina

Research Site

CABA, C1425HFA

Argentina

Research Site

Ciudad de Buenos Aires, C1094AAD

Argentina

Research Site

Ramos Mejía, B1704ETD

Argentina

Research Site

Rosario, S2000PBJ

Argentina

Research Site

San Nicolás, B2900DMH

Argentina

Research Site

Belo Horizonte, 30150-320

Brazil

Research Site

Campinas, 13060-080

Brazil

Research Site

Campinas, 13060-803

Brazil

Research Site

São Paulo, 01236-030

Brazil

Research Site

São Paulo, 04039-002

Brazil

Research Site

São Paulo, 04266-010

Brazil

Research Site

Calgary, Alberta T2V 4J2

Canada

Research Site

Calgary, Alberta T3R 1W9

Canada

Research Site

Surrey, British Columbia V3T 4G8

Canada

Research Site

Vancouver, British Columbia V5Y 3W2

Canada

Research Site

Guelph, Ontario N1H 1B1

Canada

Research Site

Hamilton, Ontario L8L 5G8

Canada

Research Site

Stouffville, Ontario L4A1H2

Canada

Research Site

Toronto, Ontario M4G3E8

Canada

Research Site

Joliette, Quebec J6E 6A9

Canada

Research Site

Montreal, Quebec H4J 1E3

Canada

Research Site

Beijing, 100034

China

Research Site

Changchun, 130041

China

Research Site

Chengdu, 610072

China

Research Site

Chengdu, 611130

China

Research Site

Guangzhou, 510280

China

Research Site

Huzhou, 313003

China

Research Site

Nanjing, 210008

China

Research Site

Nanjing, 210009

China

Research Site

Ningbo, 315000

China

Research Site

Aarhus N, 8200

Denmark

Research Site

Gandrup, 9362

Denmark

Research Site

Herlev, 2730

Denmark

Research Site

Herlev, 2730

Denmark

Research Site

Holbæk, 4300

Denmark

Research Site

Hvidovre, 2650

Denmark

Research Site

Middelfart, 5500

Denmark

Research Site

Odense, 5000

Denmark

Research Site

Vejle, 7100

Denmark

Research Site

Holon, 5822012

Israel

Research Site

Jerusalem, 91120

Israel

Research Site

Kfar Saba, 4428164

Israel

Research Site

Petah Tikva, 49100

Israel

Research Site

Petah Tikva, 4937211

Israel

Research Site

Tel Aviv, 64239

Israel

Research Site

Chūōku, 103-0002

Japan

Research Site

Ichinomiya-shi, 491-8558

Japan

Research Site

Izunokuni-shi, 410-2295

Japan

Research Site

Kamakura-shi, 247-0056

Japan

Research Site

Kawagoe-shi, 350-0851

Japan

Research Site

Kitakyushu-shi, 802-0077

Japan

Research Site

Kyoto, 607-8062

Japan

Research Site

Kyoto, 612-8555

Japan

Research Site

Mito, 311-4153

Japan

Research Site

Nishinomiya-shi, 662-0971

Japan

Research Site

Ōmihachiman, 523-0082

Japan

Research Site

Yokohama, 230-8765

Japan

Research Site

Linköping, 58213

Sweden

Research Site

Lund, 222 22

Sweden

Research Site

Mölndal, 43153

Sweden

Research Site

Örebro, 703 62

Sweden

Research Site

Stockholm, 113 61

Sweden

Research Site

Ankara, 06100

Turkey (Türkiye)

Research Site

Ankara, 06800

Turkey (Türkiye)

Research Site

Antalya, 07059

Turkey (Türkiye)

Research Site

Center, 23200

Turkey (Türkiye)

Research Site

Istanbul, 34384

Turkey (Türkiye)

Research Site

Airdrie, ML6 0JS

United Kingdom

Research Site

Chippenham, SN14 6GT

United Kingdom

Research Site

Hull, HU3 2PA

United Kingdom

Research Site

Llandough, CF64 2XX

United Kingdom

Research Site

Rotherham, S65 1DA

United Kingdom