NCT07351058

Brief Summary

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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for phase_3

Timeline
27mo left

Started Mar 2026

Geographic Reach
7 countries

36 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Aug 2028

First Submitted

Initial submission to the registry

January 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

January 16, 2026

Last Update Submit

April 21, 2026

Conditions

Type 2 Diabetes MellitusObesity or Overweight

Outcome Measures

Primary Outcomes (1)

  • Percent (%) Change from Baseline in Body Weight at Week 72

    Baseline through Week 72

Secondary Outcomes (40)

  • Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72

    Baseline and Week 72

  • Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72

    Baseline and Week 72

  • Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72

    Baseline and Week 72

  • Change from Baseline in Body Weight (kg) at Week 72

    Baseline through Week 72

  • Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72

    Baseline through Week 72

  • +35 more secondary outcomes

Study Arms (4)

Arm 1: Placebo

PLACEBO COMPARATOR
Combination Product: Placebo

Arm 2: Enicepatide Dosing Regimen 1

EXPERIMENTAL
Combination Product: Enicepatide

Arm 3: Enicepatide Dosing Regimen 2

EXPERIMENTAL
Combination Product: Enicepatide

Arm 4: Enicepatide Dosing Regimen 3

EXPERIMENTAL
Combination Product: Enicepatide

Interventions

PlaceboCOMBINATION_PRODUCT

Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.

Arm 1: Placebo
EnicepatideCOMBINATION_PRODUCT

Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Also known as: RO7795068, CT-388, RG6640
Arm 2: Enicepatide Dosing Regimen 1Arm 3: Enicepatide Dosing Regimen 2Arm 4: Enicepatide Dosing Regimen 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
  • Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
  • Body mass index (BMI) ≥27.0 kg/m\^2
  • History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

You may not qualify if:

  • History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
  • Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
  • At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
  • Self-reported change in body weight \>5 kg within 3 months prior to screening
  • Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
  • Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
  • Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
  • Poorly controlled hypertension at screening
  • Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
  • Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Lakeview Clinical Research

Guntersville, Alabama, 35976, United States

RECRUITING

Arizona Clinical Trials

Tucson, Arizona, 85711, United States

RECRUITING

Orange County Research Center

Lake Forest, California, 92630, United States

RECRUITING

Ark Clinical Research

Long Beach, California, 90815, United States

RECRUITING

Catalina Research Institute, LLC

Montclair, California, 91763, United States

RECRUITING

Prospective Research Innovations Inc.

Rancho Cucamonga, California, 91730, United States

RECRUITING

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20009, United States

RECRUITING

Progressive Medical Research

Port Orange, Florida, 32127, United States

RECRUITING

Elevate Clinical Research

Lake Charles, Louisiana, 70605, United States

RECRUITING

Centennial Medical Group

Columbia, Maryland, 21045-5840, United States

RECRUITING

Centricity Research Morehead City Multispeciality

Morehead City, North Carolina, 28557, United States

RECRUITING

Remington Davis Inc

Columbus, Ohio, 43215, United States

RECRUITING

Essential Medical Research

Tulsa, Oklahoma, 74137, United States

RECRUITING

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

RECRUITING

Circle Clinical Research

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Velocity Clinical Research

Dallas, Texas, 75230, United States

RECRUITING

Juno Research, LLC

Houston, Texas, 77040, United States

RECRUITING

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

RECRUITING

Era Health Research

Redmond, Washington, 98052, United States

RECRUITING

CINME

Buenos Aires, C1056ABI, Argentina

RECRUITING

Paratus Clinical Western Sydney

Blacktown, New South Wales, 2148, Australia

RECRUITING

TGElliott Inc. dba BC Diabetes

Vancouver, British Columbia, V5Y 3W2, Canada

RECRUITING

Centricity Research Brampton Endocrinology

Brampton, Ontario, L6S 0C6, Canada

RECRUITING

LMC Clinical Research Inc

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

Kasugai Municipal Hospital

Aichi, 486-8510, Japan

RECRUITING

Hasegawa Medicine Clinic

Hokkaido, 066-0032, Japan

RECRUITING

Higashijujo Sakai Diabetes Internal Medicine Clinic

Tokyo, 114-0001, Japan

RECRUITING

Changhua Christian Hospital

Changhua, 50006, Taiwan

RECRUITING

Chia-Yi Christian Hospital

Chiayi City, 600, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

RECRUITING

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10048, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Division of Endocrinology and Metabolism;Internal Medicine

Chiang Mai, 50200, Thailand

RECRUITING

MeSH Terms

Conditions

ObesityOverweightDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WC45726 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 20, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

August 7, 2028

Study Completion (Estimated)

August 7, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Locations

US(19)TW(8)CA(3)JP(3)TH(1)AU(1)AR(1)