A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT07351045
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Obesity or Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — COMBINATION_PRODUCT
    Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
  • Enicepatide — COMBINATION_PRODUCT
    Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Study Details

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Key Dates

Start date
Mar 16, 2026
Status verified
May 2026
Primary completion
Jul 24, 2028
Completion
Aug 28, 2028

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm 1: Placebo
  • Experimental: Arm 2: Enicepatide Dosing Regimen 1
  • Experimental: Arm 3: Enicepatide Dosing Regimen 2
  • Experimental: Arm 4: Enicepatide Dosing Regimen 3

Primary Outcome Measure

Percent (%) Change from Baseline in Body Weight at Week 72 [ Time Frame: Baseline through Week 72 ]

Central Contacts

  • Reference Study ID Number: WC45725 https://forpatients.roche.com/ No attachments to email below.
    888-662-6728 (U.S. Only)
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (25)

FacilityCityStateZIPSite coordinators
Pinnacle Research GroupAnnistonAlabama36207-
Alabama Clinical TherapeuticsBirminghamAlabama35235-
University of Alabama at BirminghamBirminghamAlabama35294-3360-
Arizona Clinical TrialsTucsonArizona85711-
Artemis Institute for Clinical Research, LLCSan DiegoCalifornia92123-
Rophe Adult and Pediatric Medicine/SKYCRNGUnion CityGeorgia30291-
East-West Medical Research InstituteHonoluluHawaii96814-
Elevate Clinical ResearchGurneeIllinois60031-
KnownwellSchaumburgIllinois60194-
Monroe Biomedical ResearchLouisvilleKentucky40213-
KnownwellNeedhamMassachusetts02492-
International Diabetes Center At Park NicolletMinneapolisMinnesota55416-
Clinvest Research LLCSpringfieldMissouri65807-
Rochester Clinical ResearchBuffaloNew York14217-
Hometown Urgent Care and Research - DaytonDaytonOhio45424-
Headlands Reseach- SummitPortlandOregon97210-
Suburban Research Associates - West Chester OfficeWest ChesterPennsylvania19380-
Trial Management AssociatesMyrtle BeachSouth Carolina29572-
Circle Clinical ResearchSioux FallsSouth Dakota57104-
Innovative Clinical ResearchClarksvilleTennessee37040-
Clinical Research AssociatesNashvilleTennessee37203-
Bellaire Clinical Research, LLCBellaireTexas77401-
University of Texas Southwestern Medical Center - Children's Medical Center DallasDallasTexas75390-
Elevate ClinicalHoustonTexas77058-
Elevate ClinicalMcAllenTexas78504-

Find similar trials in Anniston, AL

By research site
Pinnacle Research Group· Anniston, ALAlabama Clinical Therapeutics· Birmingham, ALUniversity of Alabama at Birmingham· Birmingham, ALArizona Clinical Trials· Tucson, AZArtemis Institute for Clinical Research, LLC· San Diego, CARophe Adult and Pediatric Medicine/SKYCRNG· Union City, GA

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