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NCT Number: NCT07670416

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

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Mellitus (T2DM)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yan'an University Xianyang Hospital, Xianyang, Shaanxi, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enicepatide

Combination Product

Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.

Other names: RO7795068, CT-388, RG6640

Placebo

Combination Product

Participants will receive matching placebo via SC injection as per the schedule in the protocol.

Primary outcomes

  1. Percent Change From Baseline in Body Weight at Week 52

    Time frame: Baseline through Week 52

Secondary outcomes

  1. Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52

    Time frame: At Week 52

  2. Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52

    Time frame: At Week 52

  3. Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52

    Time frame: At Week 52

  4. Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3

    Time frame: At Week 52

  5. Change From Baseline in Body Weight at Week 52

    Time frame: Baseline through Week 52

  6. Change From Baseline in Waist Circumference at Week 52

    Time frame: Baseline through Week 52

  7. Change From Baseline in Fasting Glucose at Week 52

    Time frame: Baseline through Week 52

  8. Change From Baseline in Fasting Insulin at Week 52

    Time frame: Baseline through Week 52

  9. Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52

    Time frame: Baseline through Week 52

  10. Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52

    Time frame: Baseline through Week 52

  11. Change From Baseline in Triglyceride at Week 52

    Time frame: Baseline through Week 52

  12. Change From Baseline in Systolic Blood Pressure at Week 52

    Time frame: Baseline through Week 52

  13. 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

  14. 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

  15. Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations

    Time frame: Baseline through Week 52

  16. Change From Baseline in Waist-to-Hip Ratio at Week 52

    Time frame: Baseline through Week 52

  17. Change From Baseline in Waist-to-Height Ratio at Week 52

    Time frame: Baseline through Week 52

  18. Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52

    Time frame: At Week 52

  19. 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

  20. 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

  21. Change From Baseline in Non-HDL Cholesterol at Week 52

    Time frame: Baseline through Week 52

  22. Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52

    Time frame: Baseline through Week 52

  23. Change From Baseline in Total Cholesterol at Week 52

    Time frame: Baseline through Week 52

  24. Change From Baseline in Free Fatty Acids at Week 52

    Time frame: Baseline through Week 52

  25. Change From Baseline in Diastolic Blood Pressure at Week 52

    Time frame: Baseline through Week 52

  26. Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52

    Time frame: Baseline through Week 52

  27. Change From Baseline in Serum Uric Acid at Week 52

    Time frame: Baseline through Week 52

  28. 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

  29. Change From Baseline in Body Mass Index (BMI) at Week 52

    Time frame: Baseline through Week 52

  30. Percent Change From Baseline in Body Weight by Obesity Class at Week 52

    Time frame: Baseline through Week 52

  31. Change From Baseline in HbA1c at Week 52 in Participants With T2DM

    Time frame: Baseline through Week 52

  32. Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52

    Time frame: At Week 52

  33. Change From Baseline in Total Lean Tissue Volume at Week 52

    Time frame: Baseline through Week 52

  34. Percent Change From Baseline in Total Lean Tissue Volume at Week 52

    Time frame: Baseline through Week 52

  35. Change From Baseline in Total Adipose Tissue Volume at Week 52

    Time frame: Baseline through Week 52

  36. Percent Change From Baseline in Total Adipose Tissue Volume at Week 52

    Time frame: Baseline through Week 52

  37. 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)

  38. Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    Time frame: Baseline through Week 52

  39. Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score

    Time frame: Baseline through Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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