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A Study to Assess the Efficacy, Safety and Tolerability of AT673 Co-administered With Semaglutide in Adult Participants With Type 2 Diabetes (T2D) and Overweight or Obesity

31 août 2026 mis à jour par: Antag Therapeutics

A Phase 2, Randomized, Double-blind, Placebo-Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of AT673 Co-administered With Semaglutide in Adult Participants With Type 2 Diabetes (T2D) and Overweight or Obesity

The goal of this clinical trial is to learn if AT673 contributes to additional weight loss and glycemic control when given with semaglutide in participants with overweight/obesity and type 2 diabetes. The main questions it aims to answer are:

  • To compare the effect on body weight of two doses of AT673 once-weekly versus matched placebo when concurrently administered with semaglutide once-weekly
  • To evaluate the effect of AT673 on glycated hemoglobin (HbA1c)
  • To compare the safety and tolerability of AT673 versus matched placebo when concurrently administered with semaglutide

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a phase 2, double-blind, placebo-controlled study. Following screening, at their baseline visit, participants will initiate treatment with semaglutide at 0.25 mg/week and follow the product labelled dose escalation schedule until reaching the dose of 1.0 mg/week. Participants will remain on this dose until the end of study (EOS) visit.

At the baseline visit, participants will be randomized in a 1:1:1 ratio to receive AT673 25 mg, or 50 mg, or matching placebo, respectively, once weekly at the same time as semaglutide.

Participants will receive AT673 / placebo injections concurrently with Semaglutide during weekly clinic visits. Treatment with the AT673 / placebo will continue through the end of 13 weeks. This will be followed by a 4-week safety follow-up. The end of study visit will be at week 17.

Type d'étude

Interventionnel

Inscription (Estimé)

150

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Arizona
      • Chandler, Arizona, États-Unis, 85224
        • Recrutement
        • CenExel Phoenix
        • Contact:
        • Chercheur principal:
          • Pallavi Joshi, DO
    • California
      • Anaheim, California, États-Unis, 92801
        • Recrutement
        • CenExel Anaheim
        • Contact:
          • Silvia Monico Recruitment Manager
          • Numéro de téléphone: 714-774-7777
          • E-mail: s.monico@cenexel.com
        • Chercheur principal:
          • Amina Haggag, MD, FAAFP, CDCES, CPI
    • Florida
      • Hollywood, Florida, États-Unis, 33024
        • Recrutement
        • CenExel Hollywood
        • Chercheur principal:
          • Craig Shapiro, DO, FAOCO
        • Contact:
          • May Fernandez Director of Clinical Operations
          • Numéro de téléphone: 954-990-7649
          • E-mail: m.fernandez@cenexel.com
      • Tampa, Florida, États-Unis, 33613
        • Recrutement
        • CenExel Tampa
        • Contact:
          • Beth DeLuca Director of Recruitment
          • Numéro de téléphone: 813-264-2155
          • E-mail: e.deluca@cenexel.com
        • Chercheur principal:
          • Deborah White, MD
    • Georgia
      • Atlanta, Georgia, États-Unis, 30331
        • Recrutement
        • CenExel Atlanta
        • Contact:
        • Chercheur principal:
          • Elisa Barron, MD
      • Decatur, Georgia, États-Unis, 30030
        • Recrutement
        • CenExel Decatur
        • Chercheur principal:
          • Kimball Johnson, MD
        • Contact:
      • Savannah, Georgia, États-Unis, 31405
        • Recrutement
        • CenExel Savannah
        • Contact:
          • Michelle Lagares Recruitment Specialist
          • Numéro de téléphone: 912-744-0800
          • E-mail: m.lagares@cenexel.com
        • Chercheur principal:
          • Marilyn Lavalle, MD
    • Utah
      • Salt Lake City, Utah, États-Unis, 84107
        • Recrutement
        • CenExel SLC
        • Contact:
          • Jenny Hunt Recruitment Manager
          • Numéro de téléphone: 801-261-2000
          • E-mail: j.hunt@cenexel.com
        • Chercheur principal:
          • Ryan Black, DO

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Signed informed consent prior to start the Screening Visit procedures.
  2. Female and male participants ≥18 years of age at time of consent
  3. BMI g ≥27.0 kg/m2 at screening.
  4. HbA1c ≥7 and ≤10% (53-86 mmol/mol) at screening.
  5. Diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening.

  6. Either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, sulfonylurea, and/or DPP4 inhibitor as monotherapy or combination therapy, per approved local label.

    a) Note: Participants treated with sulfonylureas and/or DPP4 inhibitors must discontinue these at least 24 hours prior to initiation of semaglutide.

  7. Participant has had at least 1 unsuccessful attempt at weight loss by diet and exercise in the opinion of the investigator.

  8. Women of childbearing potential (WOCBP) meeting the criteria below:

    i) Non-lactating and has a negative pregnancy test at screening and baseline -AND- ii) Uses an acceptable method of contraception as determined by the Investigator or Sub-Investigator for the duration of the study and 30 days following the last dose of study drug

  9. Participants must, in the opinion of the Investigator, be suitable candidates to receive semaglutide (Wegovy®) as indicated according to the product label.

Exclusion Criteria:

  1. Participant has had gastric bypass or other bariatric surgery or endoscopic procedure or any metabolic procedures (e.g. duodenal resurfacing, intragastric balloon, etc.) except for the following:

    1. Liposuction and/or abdominoplasty that was performed > 1 year before screening
    2. Laparoscopic gastric band that was removed > 1 year before screening
    3. Intragastric balloon that was removed > 1 year before screening
    4. Duodenal-jejunal bypass sleeve that was removed > 1 year before screening.
  2. Participant has had a self-reported or medically recorded change in body weight > 5% within 3 months of screening OR has recorded change in body weight >3% between screening and randomization.
  3. Participant is currently using insulin or used insulin within 3 months before screening.
  4. Participant is currently using sulfonylureas and/or DPP4 inhibitors and is unable or unwilling to discontinue the use of these medications at least 24 hours prior to initiation of semaglutide.

  5. Participant has a form of diabetes other than type 2.

    a. Note: Previous diagnosis of gestational diabetes is permitted so long as the participant meets all inclusion and none of the exclusion criteria.

  6. Participant is currently using or used within 3 months before screening any weight reducing medication including pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, naltrexone, bupropion.
  7. Participant is currently using or used within 6 months before screening any medication that contains a GLP-1R agonist component or a GIPR modulator (either by prescription or as part of a clinical study)

  8. For participants with a history of prior GLP-1R agonist use (> 6 months prior to screening):

    1. Participant has had a previous intolerance or hypersensitivity to GLP-1 receptor agonists or any of its excipients.
    2. Participant has previously discontinued a GLP-1 receptor agonist after continuous treatment for 6 months or longer due to not meeting personal weight loss goals.
  9. Participant is taking any medication that, may cause weight gain unless the participant has used these medications for more than 6 months at a stable dose prior to screening.
  10. Participant has hepatic liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase levels >2.5, or total bilirubin levels > 1.5 times the upper limit of normal (ULN) at screening.
  11. Participant's current alcohol intake exceeds 14 units/week for men or 7 units/week for women (1 unit = half pint of beer, 1 glass of wine, 1 measure of spirits).
  12. Participant has a recent history of illicit substance use (< 3 months) or in the opinion of the Investigator suspicion of current illicit substance use.
  13. Participant has uncontrolled hypertension at screening (SBP above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg).
  14. A corrected QT interval (QTc) of > 450 msec in males or > 470 msec in females at screening, or history of long QT syndrome.
  15. Concurrent participation in another interventional study (e.g., of a drug, over the counter product, device) or within ≤90 days or 5 half-lives prior to Screening.
  16. Participant is unable to understand and communicate with the investigators; or to understand the protocol requirements, instructions, study-related restrictions, nature, scope, and possible consequences of the clinical study; or is unlikely to comply with the study requirements (e.g., uncooperative attitude and improbability of completing the clinical study).
  17. Participant is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the study, or employee of the sponsor, site, or Contract Research Organization (CRO).
  18. Participant whose obesity can be traced to a medical cause, suggestive of genetic or syndromic obesity of an endocrinologic disorder (e.g., hypothyroidism, Cushings syndrome, Prader-Willi syndrome).
  19. Participant has a history of an active or untreated malignancy or in remission from a clinically significant malignancy for less than 5 years, except for basal cell carcinoma.
  20. Participant has a glomerular filtration rate < 60 mL/min/1.73 m2.
  21. Participant has a history of major psychiatric disorders within 5 years or lifetime history of suicide attempt.
  22. Participant has any suicidal ideation of type 4 or 5 on the C-SSRS at screening.
  23. Participant with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia (MEN) syndrome type 2.
  24. Participant with a previous history of chronic pancreatitis, or acute pancreatitis within 6 months prior to screening.
  25. In the opinion of the Investigator, any disorder, condition, inability or unwillingness not covered by the exclusion criteria that may interfere with study procedures, assessments or participant's safety.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Low dose
Low dose AT673, subcutaneous injection administered weekly
Médicament: AT673 low dose
low dose
Expérimental: High dose
High dose AT673 subcutaneous injection administered weekly
Médicament: AT673 high dose
high dose
Comparateur placebo: Placebo
matching placebo subcutaneous injection administered weekly
Médicament: Placebo
placebo correspondant

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Body weight
Délai: 13 weeks
Percent change in body weight from baseline to week 13
13 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
HbA1c
Délai: 13 weeks
Absolute change from baseline to week 13 in blood concentration of HbA1c (%, mmol/mol)
13 weeks
Safety and Tolerability
Délai: 13 weeks
Frequency, severity and seriousness of treatment emergent AEs
13 weeks
Achieving clinically significant body weight loss from baseline to week 13
Délai: week 13
Proportion of participants achieving >5%, and >10% body weight loss from baseline to week 13
week 13
Assess treatment effect on Body Mass Index
Délai: 13 weeks
13 weeks
Assess the treatment effect on insulin
Délai: 13 weeks
13 weeks
Assess the treatment effect on blood pressure
Délai: 13 weeks
13 weeks
Assess the treatment effect on markers of inflammation (hsCRP)
Délai: 13 weeks
13 weeks
Assess the treatment effect on lipid parameters
Délai: 13 weeks
13 weeks
Assess treatment effect on waist circumference
Délai: 13 weeks
13 weeks
Assess the treatment effect on fasting plasma glucose
Délai: 13 weeks
13 weeks
Assess the treatment effect on HOMA-IR
Délai: 13 weeks
13 weeks
Assess the treatment effect on heart rate
Délai: 13 weeks
13 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Antag Therapeutics

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 juin 2026

Achèvement primaire (Estimé)

1 février 2027

Achèvement de l'étude (Estimé)

1 mars 2027

Dates d'inscription aux études

Première soumission

14 juillet 2026

Première soumission répondant aux critères de contrôle qualité

20 juillet 2026

Première publication (Réel)

24 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 août 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AT673-OB-200

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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