A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Carmot Therapeutics, Inc.
Study ID
NCT06628362
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Overweight or Obese
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo will be volume-matched and administered subcutaneously (SC) once weekly.
  • Enicepatide — DRUG
    Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.

Study Details

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).

Key Dates

Start date
Nov 21, 2024
Status verified
Apr 2026
Primary completion
Jun 1, 2026
Completion
Sep 24, 2026

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm 1: Placebo
  • Experimental: Arm 2: Enicepatide Dose Level 1 (Low)
  • Experimental: Arm 3: Enicepatide Dose Level 2
  • Experimental: Arm 4: Enicepatide Dose Level 3
  • Experimental: Arm 5: Enicepatide Dose Level 4 (High)

Primary Outcome Measure

Percent Change in Body Weight from Baseline to Week 36 [ Time Frame: Baseline to Week 36 ]

Locations (52)

FacilityCityStateZIPSite coordinators
Central Alabama ResearchBirminghamAlabama35209-8401-
University of Alabama at Birmingham (UAB)BirminghamAlabama35233-
Lakeview Clinical Research, LLCGuntersvilleAlabama35976-
Yuma Clinical TrialsYumaArizona85364-
AMCR InstituteEscondidoCalifornia92025-
Ark Clinical-Fountain ValleyFountain ValleyCalifornia92708-
Orange Country Research CenterLake ForestCalifornia92630-
Ark Clinical ResearchLong BeachCalifornia90806-
Catalina Research Institute, LLCMontclairCalifornia91763-
Asclepes Research CentersSherman OaksCalifornia91403-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
Flourish Research - Boca RatonBoca RatonFlorida33434-
Tampa Bay Medical ResearchClearwaterFlorida33761-
K2 Medical Research, LLC - MaitlandMaitlandFlorida32751-
K2 Medical Research, LLC - OrlandoMaitlandFlorida32751-
Flourish Research Acquisition, LLCMiamiFlorida33138-
K2 Medical Research, LLC - South OrlandoOrlandoFlorida32806-
Aging Well AssociatesSt. PetersburgFlorida33713-
K2 Medical Research TampaTampaFlorida33607-
K2 Summit ResearchThe VillagesFlorida32159-
Privia Medical Group Georgia, LLCFayettevilleGeorgia30214-
Privia Medical Group Georgia - ThomasvilleThomasvilleGeorgia31792-
Rophe Adult and Pediatric Medicine/SKYCRNGUnion CityGeorgia30291-
Duly Health and CareLombardIllinois60148-
McFarland ClinicAmesIowa50010-
Cotton O'Neil Clinical Research CenterTopekaKansas66606-
NOLA Cares, LLCMetairieLouisiana70006-
Flourish Research Acquisition, LLC dba Flourish BowieBowieMaryland20715-
Centennial Medical GroupElkridgeMaryland21075-
NECCR PrimaCare Research LLCFall RiverMassachusetts02721-
Olive Branch Family Medical Center; Family MedicineOlive BranchMississippi38654-
SKY Integrative Medical Center/SKYCRNGRidgelandMississippi39157-
University of Nebraska Medical CenterOmahaNebraska68198-
Ellipsis Research GroupBrooklynNew York11215-
Accellacare of CaryCaryNorth Carolina27518-
Accellacare - HickoryHickoryNorth Carolina28601-
Accellacare of Rocky MountRocky MountNorth Carolina27804-
Accellacare of Piedmont HealthcareStatesvilleNorth Carolina28625-
Accellacare of Wilmington, LLCWilmingtonNorth Carolina28401-
Accellacare Research of Winston SalemWinston-SalemNorth Carolina27103-
Diabetes and Endocrinology Associates of Stark County, Inc.CantonOhio44718-
Tekton ResearchEdmondOklahoma73013-
Roper St. Francis Physician Partners - Primary CareMt. PleasantSouth Carolina29464-
Norwood Family MedicineKnoxvilleTennessee37912-
Summit-Halls Family PracticeKnoxvilleTennessee37938-
FutureSearch Trials of NeurologyAustinTexas78731-
University of Texas Southwestern Medical Center Investigation Drug ServicesDallasTexas75390-
Velocity Clinical Research - DallasDallasTexas75230-
Juno Research, LLCHoustonTexas77040-
Consano Clinical ResearchShavano ParkTexas78231-
Privia Medical Group North Texas - StephenvilleStephenvilleTexas76401-
Manassas Clinical Research CenterManassasVirginia20110-

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