A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Recruiting · NCT07670416 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
EnicepatidePlacebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
21 locations listed.
- Peking University People's Hospital - Beijing, China
- The Second Hospital of Jilin University - Changchun, China
- The Second Affiliated Hospital of Anhui Medical University - Hefei, China
- The Fourth Affiliated Hospital of Harbin Medical University - Herbin, China
- Huai'an First People's Hospital - Huai'an, China
- Huzhou Central Hospital - Huzhou, China
- Jinan Central Hospital - Jinan, China
- Hebei Petro China Central Hospital - Langfang, China
- Luoyang Third People's Hospital - Luoyang, China
- The Affiliated Jiangning Hospital of Nanjing Medical University - Nanjing, China
- Shanghai Tenth People's Hospital - Shanghai, China
- Shanghai East Hospital - Shanghai, China
- Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine - Shanghai, China
- Shanghai Fifth People's Hospital Affiliated to Fudan University - Shanghai, China
- The People's Hospital of Liaoning Province - Shenyang, China
- Shenyang Fifth People Hospital - Shenyang, China
- Hebei Medical University - The Second Hospital - Shijiazhuang, China
- Zibo Municipal Hospital. - Zibo, China
- The Second Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China
- Yan'an University Xianyang Hospital - Xianyang, Shaanxi, China
- The First Affiliated Hospital of Ningbo University(Ningbo First Hospital) - Ningbo, Zhejiang, China