A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

September 8, 2026 updated by: Hoffmann-La Roche

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus

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) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
      • Changchun, China, 130041
        • Recruiting
        • The Second Hospital of Jilin University
      • Hefei, China, 230601
        • Recruiting
        • The Second Affiliated Hospital of Anhui Medical University
      • Herbin, China, 150001
        • Recruiting
        • The Fourth Affiliated Hospital of Harbin Medical University
      • Huai'an, China
        • Recruiting
        • Huai'an first people's hospital
      • Huzhou, China, 313000
        • Recruiting
        • Huzhou Central Hospital
      • Jinan, China, 250013
        • Recruiting
        • Jinan Central Hospital
      • Langfang, China, 065000
        • Recruiting
        • Hebei Petro China Central Hospital
      • Luoyang, China, 471000
        • Recruiting
        • Luoyang Third People's Hospital
      • Nanjing, China, 211100
        • Recruiting
        • The Affiliated Jiangning Hospital of Nanjing Medical University
      • Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital
      • Shanghai, China, 200072
        • Recruiting
        • Shanghai Tenth People's Hospital
      • Shanghai, China, 201304
        • Recruiting
        • Shanghai Fifth People's Hospital affiliated to Fudan University
      • Shanghai, China, 200336
        • Recruiting
        • Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shenyang, China, 110074
        • Recruiting
        • Shenyang Fifth People Hospital
      • Shenyang, China, 110016
        • Recruiting
        • The People's Hospital of Liaoning Province
      • Shijiazhuang, China, 050004
        • Recruiting
        • Hebei Medical University - The Second Hospital
      • Zibo, China, 255400
        • Recruiting
        • Zibo Municipal Hospital.
    • Henan
      • Zhengzhou, Henan, China, 450014
        • Recruiting
        • The Second Affiliated Hospital of Zhengzhou University
    • Shaanxi
      • Xianyang, Shaanxi, China, 712000
        • Recruiting
        • Yan'an University Xianyang Hospital
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m^2) for participants with type 2 diabetes mellitus (T2DM)
  • BMI ≥28.0 kg/m^2 or BMI ≥24.0 and <28.0 kg/m^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM
  • Agreement to adhere to the contraception requirements

Exclusion Criteria:

  • History of Type 1 diabetes mellitus (T1DM)
  • Obesity induced by other endocrinologic disorders
  • Any planned major medical procedure or surgery during the study
  • History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
  • Any lifetime history of suicide attempt
  • History of any hematologic conditions that may interfere with HbA1c measurement
  • History of acute or chronic pancreatitis or clinically significant gallbladder disease
  • Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization
  • Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer
  • Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants will receive matching placebo.
Combination product: Placebo
Participants will receive matching placebo via SC injection as per the schedule in the protocol.
Experimental: Enicepatide Dose 1
Participants will receive enicepatide Dose 1.
Combination product: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Other Names:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Enicepatide Dose 2
Participants will receive enicepatide Dose 2.
Combination product: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Other Names:
  • RO7795068
  • RG6640
  • CT-388
Experimental: Enicepatide Dose 3
Participants will receive enicepatide Dose 3.
Combination product: Enicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Other Names:
  • RO7795068
  • RG6640
  • CT-388

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change From Baseline in Body Weight at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52
Time Frame: At Week 52
At Week 52
Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52
Time Frame: At Week 52
At Week 52
Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52
Time Frame: At Week 52
At Week 52
Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3
Time Frame: At Week 52
At Week 52
Change From Baseline in Body Weight at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist Circumference at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Fasting Glucose at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Fasting Insulin at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Triglyceride at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Systolic Blood Pressure at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in the Physical Functioning as Assessed by Short Form 36 Health Survey Acute, Version 2.0 (SF-36 v2 Acute) at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Physical Functioning Composite Score as Assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist-to-Hip Ratio at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Waist-to-Height Ratio at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52
Time Frame: At Week 52
At Week 52
Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Domain Scores and Component Summary Scores at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Questionnaire Domain Scores and Total Score at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Non-HDL Cholesterol at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Total Cholesterol at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Free Fatty Acids at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Diastolic Blood Pressure at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Serum Uric Acid at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Body Mass Index (BMI) at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Body Weight by Obesity Class at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in HbA1c at Week 52 in Participants With T2DM
Time Frame: Baseline through Week 52
Baseline through Week 52
Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52
Time Frame: At Week 52
At Week 52
Change From Baseline in Total Lean Tissue Volume at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Total Lean Tissue Volume at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in Total Adipose Tissue Volume at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Percent Change From Baseline in Total Adipose Tissue Volume at Week 52
Time Frame: Baseline through Week 52
Baseline through Week 52
Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria
Time Frame: Baseline to Safety Follow-Up (55 Weeks)
Baseline to Safety Follow-Up (55 Weeks)
Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time Frame: Baseline through Week 52
Baseline through Week 52
Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score
Time Frame: Baseline through Week 52
Baseline through Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YC46401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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