RecruitingPhase 3interventionalRules rewrite

Phase 3: Placebo for Obesity or Overweight

This study wants to assess the how well it works and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with dummy treatment (placebo) for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Official registry: https://clinicaltrials.gov/study/NCT07351058 · Hoffmann-La Roche · enrollment listed as 1,600

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Placebo, or Enicepatide. The registry lists allocation as randomized. This study wants to assess the how well it works and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with dummy treatment (placebo) for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).

They plan to enroll about 1,600 people at 222 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes

Interventions: Placebo, Enicepatide

Primary outcome (registry wording): Percent (%) Change from Baseline in Body Weight at Week 72

Who it is for (from inclusion criteria)

Ages 18 Years to any
Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
Body mass index (body-mass index (BMI)) ≥27.0 kg/m\^2
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

Who the registry excludes

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)

Public study contact (from the registry)

Reference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below.

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

global-roche-genentech-trials@gene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

222 listed

Lakeview Clinical Research — Guntersville, Alabama (recruiting)
Arizona Clinical Trials — Tucson, Arizona (recruiting)
University of California Irvine — Irvine, California (recruiting)
Orange County Research Center — Lake Forest, California (recruiting)
Ark Clinical Research — Long Beach, California (recruiting)
Catalina Research Institute, LLC — Montclair, California (recruiting)
Infinity Clinical Research — Norco, California (recruiting)
Prospective Research Innovations Inc. — Rancho Cucamonga, California (recruiting)
Encompass Clinical Research — Spring Valley, California (recruiting)
Emerson Clinical Research Institute — Washington D.C., District of Columbia (recruiting)
Tampa Bay Medical Research, Inc. — Clearwater, Florida (recruiting)
Center for Diabetes, Obesity and Metabolism Inc — Pembroke Pines, Florida (recruiting)

+ 177 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07351058 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07351058?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07351058?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary