NCT07351045

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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
28mo left

Started Mar 2026

Geographic Reach
6 countries

28 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 Progress6%
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 16, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 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

Obesity or Overweight

Outcome Measures

Primary Outcomes (1)

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

    Baseline through Week 72

Secondary Outcomes (43)

  • 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

  • Percentage of Participants Achieving ≥20% Body Weight Loss from Baseline at Week 72

    Baseline and Week 72

  • Percentage of Participants Achieving ≥25% Body Weight Loss from Baseline at Week 72

    Baseline and Week 72

  • +38 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:

  • Participants must have at screening:
  • Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
  • BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
  • History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
  • Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)

You may not qualify if:

  • History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
  • 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)
  • History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
  • Poorly controlled hypertension at screening
  • 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.
  • Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
  • 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 (28)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

RECRUITING

Arizona Clinical Trials

Tucson, Arizona, 85711, United States

RECRUITING

Artemis Institute for Clinical Research, LLC

San Diego, California, 92123, United States

RECRUITING

Elevate Clinical Research

Gurnee, Illinois, 60031, United States

RECRUITING

Monroe Biomedical Research

Louisville, Kentucky, 40213, United States

RECRUITING

International Diabetes Center At Park Nicollet

Minneapolis, Minnesota, 55416, United States

RECRUITING

Clinvest Research LLC

Springfield, Missouri, 65807, United States

RECRUITING

Headlands Reseach- Summit

Portland, Oregon, 97210, United States

RECRUITING

Trial Management Associates

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Clinical Research Associates

Nashville, Tennessee, 37203, United States

RECRUITING

Elevate Clinical

Houston, Texas, 77058, United States

RECRUITING

Elevate Clinical

McAllen, Texas, 78504, United States

RECRUITING

CINME

Buenos Aires, C1056ABI, Argentina

RECRUITING

Paratus Clinical Western Sydney

Blacktown, New South Wales, 2148, Australia

RECRUITING

Aggarwal and Associates

Brampton, Ontario, L6T 0G1, Canada

RECRUITING

Wharton Medical Clinic

Hamilton, Ontario, L8L 5G8, Canada

RECRUITING

Kasugai Municipal Hospital

Aichi, 486-8510, Japan

RECRUITING

NTT Medical Center Sapporo

Hokkaido, 060-0061, 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

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WC45725 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 16, 2026

Primary Completion (Estimated)

July 24, 2028

Study Completion (Estimated)

August 28, 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(12)AU(1)CA(2)AR(1)JP(4)TW(8)