Clinical trial

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

Recruiting now · Phase 3 · 1 countries · Registry ID NCT07670416

Recruiting nowPhase 3Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight, Type 2 Diabetes Mellitus (T2DM)

Full registry 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

Treatments and study arms

Enicepatide

Combination Product

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

Placebo

Combination Product

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

Primary outcomes

Percent Change From Baseline in Body Weight at Week 52Baseline through Week 52

Study locations

18 locations were listed when this page was built. The first 40 are shown.

Peking University People's Hospital🇨🇳 Beijing, China
The Second Affiliated Hospital of Anhui Medical University🇨🇳 Hefei, 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
The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)🇨🇳 Ningbo, Zhejiang, China
Shanghai East Hospital🇨🇳 Shanghai, China
Shanghai Fifth People's Hospital Affiliated to Fudan University🇨🇳 Shanghai, China
Shanghai Tenth People's Hospital🇨🇳 Shanghai, China
Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine🇨🇳 Shanghai, China
Shenyang Fifth People Hospital🇨🇳 Shenyang, China
Hebei Medical University - The Second Hospital🇨🇳 Shijiazhuang, China
Yan'an University Xianyang Hospital🇨🇳 Xianyang, Shaanxi, China
The Second Affiliated Hospital of Zhengzhou University🇨🇳 Zhengzhou, Henan, China
Zibo Municipal Hospital.🇨🇳 Zibo, China