Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

20 luglio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

150

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Chandler, Arizona, Stati Uniti, 85224
        • Reclutamento
        • CenExel Phoenix
        • Contatto:
        • Investigatore principale:
          • Henry Youga, MD
    • California
      • Anaheim, California, Stati Uniti, 92801
        • Reclutamento
        • CenExel Anaheim
        • Contatto:
        • Investigatore principale:
          • Amina Haggag, MD, FAAFP, CDCES, CPI
    • Florida
      • Hollywood, Florida, Stati Uniti, 33024
        • Reclutamento
        • CenExel Hollywood
        • Investigatore principale:
          • Craig Shapiro, DO, FAOCO
        • Contatto:
      • Tampa, Florida, Stati Uniti, 33613
        • Reclutamento
        • CenExel Tampa
        • Contatto:
        • Investigatore principale:
          • Deborah White, MD
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30331
        • Reclutamento
        • CenExel Atlanta
        • Contatto:
        • Investigatore principale:
          • Elisa Barron, MD
      • Decatur, Georgia, Stati Uniti, 30030
        • Reclutamento
        • CenExel Decatur
        • Investigatore principale:
          • Kimball Johnson, MD
        • Contatto:
      • Savannah, Georgia, Stati Uniti, 31405
        • Reclutamento
        • CenExel Savannah
        • Contatto:
        • Investigatore principale:
          • Marilyn Lavalle, MD
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84107
        • Reclutamento
        • CenExel SLC
        • Contatto:
          • Jenny Hunt Recruitment Manager
          • Numero di telefono: 801-261-2000
          • Email: j.hunt@cenexel.com
        • Investigatore principale:
          • Ryan Black, DO

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Low dose
Low dose AT673, subcutaneous injection administered weekly
Droga: AT673 low dose
low dose
Sperimentale: High dose
High dose AT673 subcutaneous injection administered weekly
Droga: AT673 high dose
high dose
Comparatore placebo: Placebo
matching placebo subcutaneous injection administered weekly
Droga: Placebo
placebo corrispondente

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body weight
Lasso di tempo: 13 weeks
Percent change in body weight from baseline to week 13
13 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
HbA1c
Lasso di tempo: 13 weeks
Absolute change from baseline to week 13 in blood concentration of HbA1c (%, mmol/mol)
13 weeks
Safety and Tolerability
Lasso di tempo: 13 weeks
Frequency, severity and seriousness of treatment emergent AEs
13 weeks
Achieving clinically significant body weight loss from baseline to week 13
Lasso di tempo: 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
Lasso di tempo: 13 weeks
13 weeks
Assess the treatment effect on insulin
Lasso di tempo: 13 weeks
13 weeks
Assess the treatment effect on blood pressure
Lasso di tempo: 13 weeks
13 weeks
Assess the treatment effect on markers of inflammation (hsCRP)
Lasso di tempo: 13 weeks
13 weeks
Assess the treatment effect on lipid parameters
Lasso di tempo: 13 weeks
13 weeks
Assess treatment effect on waist circumference
Lasso di tempo: 13 weeks
13 weeks
Assess the treatment effect on fasting plasma glucose
Lasso di tempo: 13 weeks
13 weeks
Assess the treatment effect on HOMA-IR
Lasso di tempo: 13 weeks
13 weeks
Assess the treatment effect on heart rate
Lasso di tempo: 13 weeks
13 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Antag Therapeutics

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 giugno 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

14 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 luglio 2026

Primo Inserito (Effettivo)

24 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AT673-OB-200

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Kuwait

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi