Current partner codePEPTIDESDE

A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus

Status

Recruiting

Phase

Phase 1 / Phase 2

Enrollment

150

Locations

8

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-ALK7 in adult participants with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1), and the safety, tolerability, and PD of multiple doses of ARO-ALK7 in adult participants with obesity with and without T2DM, either as monotherapy or in combination with tirzepatide (Part 2).

Interventions

Treatment arms and agents.

DRUG

ARO-ALK7

Subcutaneous (SC) injection

DRUG

Placebo

calculated volume to match active treatment by SC injection

Timeline

From registration to results.

  1. First posted

    Apr 22, 2025

  2. Study start

    May 9, 2025

  3. Primary completion

    Feb 2027

  4. Study completion

    Feb 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 8, 2026

Outcomes

What the study measures.

Primary outcomes

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Time frame · Up to Day 253 End of Study (EOS)

Secondary outcomes

Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)

Time frame · Through 48 hours post-dose

PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax)

Time frame · Through 48 hours post-dose

PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)

Time frame · Through 48 hours post-dose

PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUC0-t)

Time frame · Through 48 hours post-dose

PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to Infinity (AUC0-∞)

Time frame · Through 48 hours post-dose

PK of ARO-ALK7 (Part 1 Only): Terminal Elimination Half-life (t1/2)

Time frame · Through 48 hours post-dose

PK of ARO-ALK7 (Part 1 Only): Apparent Systemic Clearance (CL/F)

Time frame · Through 48 hours post-dose

PK of ARO-ALK7 (Part 1 Only): Apparent Terminal-phase Volume of Distribution (Vz/F)

Time frame · Through 48 hours post-dose

PK of ARO-ALK7 (Part 1 Only): Recovery of Unchanged Drug in Urine from Time 0 to 24 Hours after Dosing (Amount excreted: Ae)

Time frame · Through 24 hours post-dose

PK of ARO-ALK7 (Part 1 Only): Fraction or Percentage of Administered Drug Excreted in Urine from Time 0 to 24 Hours after Dosing (Fe)

Time frame · Through 24 hours post-dose

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Obesity, defined as body mass index (BMI) between 30-50 kilograms (kg)/square meter (m\^2), inclusive, with weight at Screening not to exceed 159 kg (350 pounds \[lbs\]) * At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification * No abnormal finding of clinical relevance at Screening that could adversely impact participant safety during the study or adversely impact study results * Female participants of childbearing potential must agree to use highly effective contraception and male participants with female partners of childbearing potential must agree to use a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, whichever is later Exclusion Criteria: * Self-reported (or documented) weight gain or loss \>5% within 3 months prior to Screening * Use of glucagon-like peptide-1 receptor agonist (GLP-1RAs) (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening * Use of non-GLP-1R medications for weight loss within 3 months prior to Screening, including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate, and other prescription or over-the-counter medication or supplement taken for weight loss purposes * Obesity attributable primarily in the Investigator's opinion to medication use, monogenic or endocrinologic disorders (other than polycystic ovary syndrome) * History of prior surgical or device-based therapy for obesity (including endoscopic bariatric procedures) * Use of medications or therapies strongly associated with weight gain, alterations in body composition, or increase in muscle mass, within 3 months prior to Screening * Type 1 diabetes mellitus Note: Additional inclusion/exclusion criteria may apply per protocol.

Study locations

8 registered sites.

Australia · New Zealand. Showing up to 24 locations stored in the fast local snapshot.

Research Site 8

Morayfield, QLC, Australia

Research Site 7

Nedlands, Western Australia, Australia

Research Site 5

Grafton, Auckland, New Zealand

Research Site 6

Papatoetoe, Auckland, New Zealand

Research Site 3

Takapuna, Auckland, New Zealand

Research Site 1

Auckland, New Zealand

Research Site 2

Christchurch, New Zealand

Research Site 4

Rotorua, New Zealand

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 Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.