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  1. Medical Information Right
  2. Investigational Drugs Right
  3. Retatrutide-Diabetes Right
  4. What retatrutide clinical trials are being conducted in people with type 2 diabetes?
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Retatrutide-Diabetes

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling.

What retatrutide clinical trials are being conducted in people with type 2 diabetes?

The TRANSCEND-T2D clinical trial program evaluates investigational doses of retatrutide for the treatment of type 2 diabetes in adults.

US_cFAQ_RETA020A_TRANSCEND_CLINICAL_TRIALS_T2D
US_cFAQ_RETA020A_TRANSCEND_CLINICAL_TRIALS_T2Den-US

TRANSCEND-T2D Clinical Trial Program: Retatrutide for the Treatment of Type 2 Diabetes

Retatrutide is a novel, synthetic molecule, which shows potent agonist action at the

  • glucose-dependent insulinotropic polypeptide receptor (GIPR),
  • glucagon-like peptide-1 receptor (GLP-1R), and
  • glucagon receptor (GCGR).1

The TRANSCEND-T2D clinical trial program assesses the efficacy and safety of investigational doses of retatrutide as a treatment for type 2 diabetes in adults (Overview of the TRANSCEND-T2D Phase 3 Clinical Trial Program of Retatrutide for the Treatment of T2D).

Overview of the TRANSCEND-T2D Phase 3 Clinical Trial Program of Retatrutide for the Treatment of T2D

Trial and Target Population

Key Inclusion Criteria

Concomitant Therapya

Retatrutide Groups

Comparator

Primary Endpoint(s)

Primary Timepoint

Global trials

TRANSCEND-T2D-12
in People With T2D

NCT06354660

  • T2D
  • HbA1c ≥7.0% to ≤9.5%
  • Naïve to insulin therapy and have not used oral or injectable antihyperglycemic medications for 90 days prior to screening
  • BMI ≥23.0 kg/m2

None

Administered SC

PBOb

CFB in HbA1c (%)

40 weeks

TRANSCEND-T2D-23
in People With T2D

NCT06260722

  • T2D
  • HbA1c ≥7.0% to ≤10.5%
  • BMI ≥25.0 kg/m2

Metformin with or without
SGLT2i

 Administered SC

SEMAb

CFB in HbA1c (%)

80 weeks

TRANSCEND-T2D-34
in People With T2D and Moderate/Severe Renal Impairment

NCT06297603

  • T2D
  • HbA1c ≥7.0% to ≤10.5%
  • Moderate or severe renal impairment
  • BMI ≥23.0 kg/m2

Basal insulin with or without metformin and/or SGLT2i

Administered SC

PBOb

CFB in HbA1c (%)

 52 weeks

Abbreviations: BMI = body mass index; CFB = change from baseline; HbA1c = glycated hemoglobin; PBO = placebo; SC = subcutaneously; SEMA = semaglutide; SGLT2i = sodium-glucose cotransporter-2 inhibitor; T2D = type 2 diabetes.

aFor the treatment of T2D.

bAdministered SC.

References

1Coskun T, Rosenstock J, Frías JP, et al. Retatrutide, a triple GIP/GLP-1/glucagon receptor agonist, provides robust HbA1c and body weight reductions to people with type 2 diabetes: a 36-week, phase 2 study. Oral presentation at: 59th Annual Meeting of the European Association for the Study of Diabetes (EASD); October 2-6, 2023; Hamburg, Germany. Accessed March 12, 2024. https://www.easd.org/media-centre/home.html#!resources/retatrutide-a-triple-gip-glp-1-glucagon-receptor-agonist-provides-robust-hba-sub-1c-sub-and-body-weight-reductions-to-people-with-type-2-diabetes-a-36-week-phase-2-study

2Effect of retatrutide compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone (TRANSCEND-T2D-1). ClinicalTrials.gov identifier: NCT06354660. Updated April 19, 2024. Accessed April 22, 2024. https://clinicaltrials.gov/study/NCT06354660

3Effect of retatrutide compared with semaglutide in adult participants with type 2 diabetes and inadequate glycemic control with metformin with or without SGLT2 inhibitor (TRANSCEND-T2D-2). ClinicalTrials.gov identifier: NCT06260722. Updated April 17, 2024. Accessed April 23, 2024. https://clinicaltrials.gov/study/NCT06260722

4Effect of retatrutide compared with placebo in participants with type 2 diabetes and moderate or severe renal impairment, with inadequate glycemic control on basal insulin, with or without metformin and/or SGLT2 inhibitor (TRANSCEND-T2D-3). ClinicalTrials.gov identifier: NCT06297603. Updated April 11, 2024. Accessed April 23, 2024. https://clinicaltrials.gov/study/NCT06297603

Date of Last Review: March 12, 2024

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