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Recruiting NCT07670416

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

Phase III Interventional Obesity Overweight Type 2 Diabetes Mellitus (T2DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enicepatide, Placebo.
Who it may be relevant to
Registry conditions: Obesity, Overweight, Type 2 Diabetes Mellitus (T2DM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Combination product Enicepatide
    Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
  • Combination product Placebo
    Participants will receive matching placebo via SC injection as per the schedule in the protocol.

Primary outcome measures

  • Percent Change From Baseline in Body Weight at Week 52 [Time frame: Baseline through Week 52]
Secondary outcome measures (12)
  • Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52 [Time frame: At Week 52]
  • Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52 [Time frame: At Week 52]
  • Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52 [Time frame: 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]
  • Change From Baseline in Body Weight at Week 52 [Time frame: Baseline through Week 52]
  • Change From Baseline in Waist Circumference at Week 52 [Time frame: Baseline through Week 52]
  • Change From Baseline in Fasting Glucose at Week 52 [Time frame: Baseline through Week 52]
  • Change From Baseline in Fasting Insulin at Week 52 [Time frame: Baseline through Week 52]
  • Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52 [Time frame: Baseline through Week 52]
  • Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52 [Time frame: Baseline through Week 52]
  • Change From Baseline in Triglyceride at Week 52 [Time frame: Baseline through Week 52]
  • Change From Baseline in Systolic Blood Pressure at Week 52 [Time frame: Baseline through Week 52]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 12 centers
  • Yan'an University Xianyang Hospital — Xianyang
  • The First Affiliated Hospital of Ningbo University(Ningbo First Hospital) — Ningbo
  • Peking University People's Hospital — Beijing
  • Jinan Central Hospital — Jinan
  • Hebei Petro China Central Hospital — Langfang
  • Luoyang Third People's Hospital — Luoyang
  • Shanghai Tenth People's Hospital — Shanghai
  • Shanghai East Hospital — Shanghai
  • … and 4 more centers

Identifiers

NCT: NCT07670416 · YC46401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗