Current partner codePEPTIDESDE
NCT07589686·Phase 2·INTERVENTIONAL

A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight

Status

Not yet recruiting

Phase

Phase 2

Enrollment

486

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.

Interventions

Treatment arms and agents.

DRUG

Petrelintide

Petrelintide will be administered subcutaneously to participants once weekly

COMBINATION_PRODUCT

Enicepatide

Enicepatide will be administered subcutaneously to participants once weekly

DRUG

Petrelintide-matching Placebo

Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly

COMBINATION_PRODUCT

Enicepatide-matching Placebo

Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly

Timeline

From registration to results.

  1. First posted

    May 15, 2026

  2. Study start

    Sep 30, 2026

  3. Primary completion

    Nov 12, 2027

  4. Study completion

    Jan 31, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 7, 2026

Outcomes

What the study measures.

Primary outcomes

Percentage Change in Body Weight between Arms 1 and 6

Time frame · From Baseline to Week 40

Secondary outcomes

Percentage Change in Body Weight between Arms 2, 3 and Arm 6

Time frame · From Baseline to Week 40

Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5

Time frame · From Baseline to Week 40

Percentage of Participants Achieving Body Weight Loss

Time frame · From Baseline to Week 40

Change in Body Weight (kilograms [kg])

Time frame · From Baseline to Week 40

Change in Body Mass Index (kilograms per square meter [kg/m²])

Time frame · From Baseline to Week 40

Change in Waist Circumference (centimeter [cm])

Time frame · From Baseline to Week 40

Change in Hemoglobin A1c (HbA1c) (percentage-points)

Time frame · From Baseline to Week 40

Change in Fasting Insulin

Time frame · From Baseline to Week 40

Change in Fasting Glucose

Time frame · From Baseline to Week 40

Change in Systolic Blood Pressure

Time frame · From Baseline to Week 40

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Key Inclusion Criteria: * Male or female participants with Body Mass Index (BMI) ≥ 30 kg/m² OR BMI ≥ 27 kg/m² to \< 30 kg/m² with at least one weight-related comorbidity * History of at least one self-reported unsuccessful dietary effort to lose body weight Key Exclusion Criteria: * HbA1c ≥ 48 mmol/mol (6.5%) at screening * History of Type 1 or Type 2 Diabetes * Self-reported change in body weight \> 5 kg within 90 days prior to screening * Previous or planned obesity treatment with surgery (excluding liposuction, cryolipolysis, or abdominoplasty if performed \> 1 year prior to or during screening) * Previous or planned endoscopic and/or device-based obesity treatment or removal or device within the last 6 months prior to screening (e.g., mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal endoluminal liner) * Treatment with any GLP-1 receptor agonist, GLP-1/GIP receptor agonist (or any other GLP-1 based treatment) within 180 days prior to or during screening * Current or previous treatment with petrelintide or any other amylin analog * Obesity induced by Cushing syndrome or a diagnosis of monogenetic or syndromic forms of obesity * History of severe psychiatric disorders * History of any hematologic conditions that may interfere with HbA1c measurement * Known history or presence of pancreatitis * Known clinically significant gastric emptying abnormality or chronic treatment that affects GI motility * New York Heart Association Functional Classification IV heart failure * Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Petrelintide.

Related PeptideStat pages

Put the record in context.

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