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

Last updated: April 27, 2026
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: 377
Treatment Group(s): 3
Primary Treatment: AZD9550
Phase: 2
Study Start date:
February 18, 2025
Estimated Completion Date:
May 25, 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

    Maroochydore 2207268, 4556
    Australia

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    Maroubra, 2035
    Australia

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    Maroubra 2158651, 2035
    Australia

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    Norwood, 5067
    Australia

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    Norwood 9973143, 5067
    Australia

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    St Albans, 3021
    Australia

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    St Albans 8015209, 3021
    Australia

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    St Leonards, 2065
    Australia

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    St Leonards 8029783, 2065
    Australia

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    Calgary, Alberta T2V 4J2
    Canada

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    Calgary 5913490, Alberta 5883102 T2V 4J2
    Canada

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    Surrey, British Columbia V3T 4G8
    Canada

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    Surrey 6159905, British Columbia 5909050 V3T 2V6
    Canada

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    Guelph, Ontario N1G 0B4
    Canada

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    Hamilton, Ontario L8J 0B6
    Canada

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    Sarnia, Ontario N7T 4X3
    Canada

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    Stouffville, Ontario L4A1H2
    Canada

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    Guelph 5967629, Ontario 6093943 N1G 0B4
    Canada

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    Hamilton 5969782, Ontario 6093943 L8J 0B6
    Canada

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    Sarnia 6141190, Ontario 6093943 N7T 4X3
    Canada

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    Stouffville 6157718, Ontario 6093943 L4A1H2
    Canada

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    Montreal, Quebec H4N 2W2
    Canada

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    Montreal 6077243, Quebec 6115047 H4N 2W2
    Canada

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    Berlin, 10787
    Germany

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    Berlin 2950159, 10787
    Germany

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    Essen, 45136
    Germany

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    Essen 2928810, 45136
    Germany

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    Falkensee, 14612
    Germany

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    Falkensee 2927930, 14612
    Germany

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    Hamburg, 22607
    Germany

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    Hamburg 2911298, 22607
    Germany

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    Mannheim, 68167
    Germany

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    Muenster, 48145
    Germany

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    Münster, 48145
    Germany

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    Münster 2867543, 48145
    Germany

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    Oldenburg, 23758
    Germany

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    Oldenburg 2857458, 23758
    Germany

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    Chuo-ku, 104-0031
    Japan

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    Chūōku, 104-0031
    Japan

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    Chūōku 10262791, 103-0027
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    Fukuoka, 812-0025
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    Fukuoka 1863967, 812-0025
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    Fukuoka-shi, 812-0025
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    Shinjuku-ku, 160-0008
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    Suita-shi, 565-0853
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    Kaohsiung, 80756
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    Centreville, Alabama 35042
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    Dothan, Alabama 36305
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    Vestavia Hills, Alabama 35216
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    Dothan 4059102, Alabama 4829764 36305
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    Vestavia Hills 4095415, Alabama 4829764 35216
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    Cerritos, California 90703
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    Escondido, California 92025
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    Huntington Park, California 90255
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    Lincoln, California 95648
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    Sacramento, California 95864
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    Cerritos 5335663, California 5332921 90703
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    Escondido 5346827, California 5332921 92025
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    Huntington Park 5358736, California 5332921 90255
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    Lincoln 5366375, California 5332921 95648
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    Sacramento 5389489, California 5332921 95864
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    Englewood, Colorado 80110
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    Waterbury, Connecticut 06708
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    Waterbury 4845193, Connecticut 4831725 06708
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    Palm Harbor, Florida 34684
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    Palm Harbor 4167545, Florida 4155751 34684
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    Decatur, Georgia 30030
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    Stockbridge, Georgia 30281
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    Decatur 4191124, Georgia 4197000 30030
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    Stockbridge 4224681, Georgia 4197000 30281
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    Meridian, Idaho 83642
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    Champaign, Illinois 61822
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    Champaign 4887158, Illinois 4896861 61822
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    South Bend, Indiana 46617
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    Valparaiso, Indiana 46383
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    South Bend 4926563, Indiana 4921868 46617
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    Valparaiso 4927537, Indiana 4921868 46383
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    Sioux City, Iowa 51106
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    Sioux City 4876523, Iowa 4862182 51106
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    Overland Park, Kansas 66210
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    Rockville, Maryland 20852
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    Southfield, Michigan 48034
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    Southfield 5010636, Michigan 5001836 48034
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    Saint Louis, Missouri 63136
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    Missoula, Montana 59804
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    Missoula 5666639, Montana 5667009 59804
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    Omaha, Nebraska 68114
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    Omaha 5074472, Nebraska 5073708 68114
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    Albuquerque, New Mexico 87107
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    Albuquerque 5454711, New Mexico 5481136 87107
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    Binghamton, New York 13905
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    Fargo, North Dakota 58104
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    Fargo 5059163, North Dakota 5690763 58104
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    Cincinnati, Ohio 45219
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    Columbus, Ohio 43213
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    Cincinnati 4508722, Ohio 5165418 45219
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    Columbus 4509177, Ohio 5165418 43213
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    Tulsa, Oklahoma 74133
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    Tulsa 4553433, Oklahoma 4544379 74133
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    Medford, Oregon 97504
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    Medford 5740099, Oregon 5744337 97504
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    Kingsport, Tennessee 37660
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    Kingsport 4634662, Tennessee 4662168 37660
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    Brownsville, Texas 78526
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    Houston, Texas 77043
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    Brownsville 4676740, Texas 4736286 78526
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    Houston 4699066, Texas 4736286 77043
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    Arlington, Virginia 22206
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    Arlington 4744709, Virginia 6254928 22206
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    Renton, Washington 98057
    United States

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  • Research Site

    Renton 5808189, Washington 5815135 98057
    United States

    Site Not Available

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