A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone

Last updated: July 23, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

AZD9550

AZD6234

Placebo comparator

Clinical Study ID

NCT06862791
D8460C00004
2024-516176-15-00
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to determine whether treatment with AZD9550 when given in combination with AZD6234 as once weekly subcutaneous (SC) injections is superior to placebo or either agent administered as monotherapy for weight loss in participants living with obesity or overweight with at least one weight-related co-morbidity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be 18 to 75 years of age inclusive.

  • BMI: ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight related comorbidity.

  • A stable, self-reported body weight for 3 months prior to screening.

  • Male and female participants: Contraceptive use by males or females should beconsistent with local regulations regarding the methods of contraception for thoseparticipating in clinical studies.

  • Female participants must have a negative serum pregnancy test at screening and anegative urine pregnancy test at baseline.

  • Capable of giving signed informed consent.

Exclusion

Exclusion Criteria:

  • History of any clinically important disease or disorder, which, in the opinion ofthe Investigator, may put the participant at risk.

  • History or presence of GI, renal, hepatic disease.

  • Previous or planned bariatric surgery or fitting of a weight loss device.

  • Obesity induced by endocrine disorders such as Cushing's syndrome, insulinoma orPrader-Willi syndrome.

  • History of T1DM or T2DM or symptoms indicative of insulinopenia or poor glucosecontrol.

  • HbA1c ≥ 6.5% (48 mmol/mol), fasting serum glucose ≥ 126 mg/dL (7.0 mmol/L) or randomglucose ≥ 200 mg/dL (11.1 mmol/L).

  • Significant gastric and hepatobiliary disease.

  • History of acute or chronic pancreatitis or pancreatic amylase or lipase > 2 × ULNat screening.

  • History of psychosis or bipolar disorder.

  • History of major depressive disorder within the 2 years prior to screening ordepression.

  • Treatment with a GLP1 containing preparation, either as part of treatment or whileparticipating in another clinical study within the 3 months or 5 half-lives of thedrug prior to screening.

  • Vulnerable populations

Study Design

Total Participants: 374
Treatment Group(s): 3
Primary Treatment: AZD9550
Phase: 2
Study Start date:
February 18, 2025
Estimated Completion Date:
June 18, 2026

Study Description

This is a Phase IIb, global, randomised, parallel-group, double-blind, placebo-controlled, multi-centre, reduced factorial study designed to evaluate the efficacy, safety and tolerability of treatment with AZD9550 and AZD6234 in combination or as monotherapy in adults who are living with obesity or overweight with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia or obstructive sleep apnoea. The study is composed of a screening period, a treatment period and a follow up period with participants expected to be in the study for approximately 47 weeks. The study will be conducted at around 60 sites and in approximately 7 countries with about, 360 participants will be randomly assigned to study intervention or placebo.

Connect with a study center

  • Research Site

    Maroochydore, 4556
    Australia

    Site Not Available

  • Research Site

    Maroubra, 2035
    Australia

    Site Not Available

  • Research Site

    Norwood, 5067
    Australia

    Site Not Available

  • Research Site

    St Albans, 3021
    Australia

    Site Not Available

  • Research Site

    St Leonards, 2065
    Australia

    Site Not Available

  • Research Site

    Calgary, Alberta T2V 4J2
    Canada

    Site Not Available

  • Research Site

    Surrey, British Columbia V3T 2V6
    Canada

    Site Not Available

  • Research Site

    Guelph, Ontario N1G 0B4
    Canada

    Site Not Available

  • Research Site

    Hamilton, Ontario L8J 0B6
    Canada

    Site Not Available

  • Research Site

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Research Site

    Stouffville, Ontario L4A1H2
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H4N 2W2
    Canada

    Site Not Available

  • Research Site

    Berlin, 10787
    Germany

    Site Not Available

  • Research Site

    Essen, 45136
    Germany

    Site Not Available

  • Research Site

    Falkensee, 14612
    Germany

    Site Not Available

  • Research Site

    Hamburg, 22607
    Germany

    Site Not Available

  • Research Site

    Mannheim, 68167
    Germany

    Site Not Available

  • Research Site

    Muenster, 48145
    Germany

    Site Not Available

  • Research Site

    Oldenburg, 23758
    Germany

    Site Not Available

  • Research Site

    Chuo-ku, 103-0027
    Japan

    Site Not Available

  • Research Site

    Fukuoka-shi, 812-0025
    Japan

    Site Not Available

  • Research Site

    Shinjuku-ku, 160-0008
    Japan

    Site Not Available

  • Research Site

    Suita-shi, 565-0853
    Japan

    Site Not Available

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • Research Site

    Centreville, Alabama 35042
    United States

    Site Not Available

  • Research Site

    Dothan, Alabama 36305
    United States

    Site Not Available

  • Research Site

    Vestavia Hills, Alabama 35216
    United States

    Site Not Available

  • Research Site

    Cerritos, California 90703
    United States

    Site Not Available

  • Research Site

    Escondido, California 92025
    United States

    Site Not Available

  • Research Site

    Huntington Park, California 90255
    United States

    Site Not Available

  • Research Site

    Lincoln, California 95648
    United States

    Site Not Available

  • Research Site

    Sacramento, California 95864
    United States

    Site Not Available

  • Research Site

    Englewood, Colorado 80110
    United States

    Site Not Available

  • Research Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Research Site

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • Research Site

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Research Site

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Research Site

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Research Site

    Champaign, Illinois 61822
    United States

    Site Not Available

  • Research Site

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Research Site

    Valparaiso, Indiana 46383
    United States

    Site Not Available

  • Research Site

    Sioux City, Iowa 51106
    United States

    Site Not Available

  • Research Site

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Research Site

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Research Site

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • Research Site

    Missoula, Montana 59804
    United States

    Site Not Available

  • Research Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Research Site

    Albuquerque, New Mexico 87107
    United States

    Site Not Available

  • Research Site

    Binghamton, New York 13905
    United States

    Site Not Available

  • Research Site

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Research Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Research Site

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Research Site

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • Research Site

    Medford, Oregon 97504
    United States

    Site Not Available

  • Research Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Research Site

    Brownsville, Texas 78526
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77043
    United States

    Site Not Available

  • Research Site

    Arlington, Virginia 22206
    United States

    Site Not Available

  • Research Site

    Renton, Washington 98057
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.