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Enicepatide for Obesity/Overweight and Type 2 Diabetes

This study is testing a medication called enicepatide (RO7795068) for people who have obesity or are overweight, and also have Type 2 Diabetes (T2DM). Enicepatide is a dual GLP-1/GIP receptor agonist, which means it works on two natural body systems that help control blood sugar and appetite. The study will compare enicepatide to a placebo (an inactive substance) to see how well it helps with weight management and if it is safe. You might be able to join if you are 18 or older, can self-administer the study drug, and have a diagnosis of Type 2 Diabetes with an HbA1c of 6.5% or higher. The main goal is to see the percentage change in body weight after 72 weeks. The study is currently unclear on its recruitment status and plans to enroll 1600 participants.

Study design
This is an interventional study comparing enicepatide to a placebo. It plans to enroll 1600 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in body weight up to Week 72.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07351058

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

Recruiting
PHASE3Ages 18+InterventionalTreatment
Hoffmann-La Roche
~1,600 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:PlaceboEnicepatide

At a glance

Recruiting sites
193 of 193 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent (%) Change from Baseline in Body Weight at Week 72
Measured over Baseline through Week 72

Conditions

Obesity or Overweight
Type 2 Diabetes Mellitus

Explore related trials

ObesityType 2 Diabetes Mellitus

Where it's being run

193 sites across 72 states
China15
Germany12
Poland9
United Kingdom9
Texas8
South Korea8
Taiwan8
Argentina7

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. Only)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
Body mass index (BMI) ≥27.0 kg/m\^2
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion

History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
Self-reported change in body weight \>5 kg within 3 months prior to screening
Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
Poorly controlled hypertension at screening
Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

What this trial measures

  • Percent (%) Change from Baseline in Body Weight at Week 72Baseline through Week 72